Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.

A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.

FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings

FACBC

External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.

Radiation therapy

Ashesh B Jani, MD, MSEE

David M Schuster, MD

Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test (anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3- \[18F\]FACBC). The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.

Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy Significant advances have been made in the technical aspects of surgery and of radiotherapy which have improved both the cancer control outcomes as well as the morbidity of treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent disease after prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (ie. recurrence in the prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence).

One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3-\[18F\]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with suspected recurrent prostate carcinoma.

The major goal in this proposed investigation is to use advanced molecular imaging to better guide post-prostatectomy decision making, in terms of guiding the decision to deliver radiotherapy, and in terms of the exact areas treated with radiotherapy.

Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test. The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.

FACBC Outcomes for Post Prostatectomy

Advanced Molecular Imaging With Anti-3-[18F]FACBC PET-CT to Improve the Selection and Outcomes of Prostate Cancer Patients Receiving Post-prostatectomy Radiotherapy

Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.

Number of decision changes regarding radiotherapy versus no radiotherapy based on F-Fluciclovine PET/CT guidance. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.

Number of decision changes regarding whole-pelvis versus local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.

Total number of radiotherapy decision changes regarding radiotherapy vs no radiotherapy and regarding whole pelvis vs local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.

Absolute volume pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.

Absolute volume were measured pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.

Standard radiotherapy dosimetric endpoints used to evaluate target coverage. Planning target volume (PTV) at V100 and V110 refer to %volume of the structure receiving 100% and 110% of the prescription dose, respectively, pre and post positron emission tomography (PET). This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.

Standard radiotherapy dosimetric endpoints used to evaluate normal tissue doses, in this case, the rectum. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.

Standard radiotherapy dosimetric endpoints are used to evaluate normal tissue doses, in this case, the bladder. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.

Provider-reported maximum acute (\<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) genitourinary toxicity based on CTCAE v4.0 criteria.

Provider-reported maximum acute (\<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) gastrointestinal toxicity ≥ Grade 2 based on CTCAE v4.0 criteria.

Patient-reported maximum genitourinary toxicity based on standard EPIC-CP questionnaire. EPIC GU domain score has a total score range 0-12. Higher score correlates with worse outcome. EPIC GU score includes the incontinence domain score and the irritative/obstructive.

Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.

Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.

Patient-reported maximum overall (genitourinary, gastrointestinal, and sexual function) toxicity based on standard EPIC-CP questionnaire. Total score range 0-60. Higher score correlates with worse outcome.

National Cancer Institute (NCI)

Emory University

Professor & Residency Program Director

Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal \[GI\] or Genitourinary \[GU\] toxicity. Acute toxicity was measured \<90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention.

Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.

A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.

FACBC: FACBC is given intravenously prior to PET scan

FACBC PET Scan

Conventional-Only Imaging

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Pathological grade was measured on the prostatectomy specimen. Gleason Grading goes from 2 thru 10, with higher scores being worse prognostically. Gleason scores of 8 and higher are considered high-grade, so this measure was designed to see whether the percentage of high-grade patients was balanced.

Gleason score ≥8

Ave PSA before radiotherapy

Dr. Ashesh Jani

This outcome evaluated the failure-free survival difference (among those who received radiotherapy) between the trial group (in which FACBC PET scan was used) versus the control group (in which conventional-only imaging was used).

FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.

Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.

Failure-free Survival

This outcome evaluated number of decision changes regarding the overall use of radiotherapy in the FACBC PET scan group only.

Decision Changes Regarding Radiotherapy Versus no Radiotherapy

This outcome evaluated number of decision changes regarding changes from whole-pelvis to local fields and vice versa (local fields to whole pelvis) in the FACBC PET scan group only.

Decision Changes Regarding Whole-pelvis Versus Local Fields

This outcome evaluated number of all radiotherapy-related decision changes in the FACBC PET scan group only.

Total Number of Decision Changes

Pre-PET

Post-PET

Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.

FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.

Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.

Prostate Bed Clinical Target Volume (CTV)

Prostate Bed Planning Target Volume (PTV)

PTV2/PTV, V100% pre PET

PTV2/PTV, V100% post PET

PTV2/PTV, V110% pre PET

PTV2/PTV, V110% post PET

PTV Dosimetric Endpoints

Rectum, V40 pre PET

Rectum, V40 post PET

Rectum, V65 pre PET

Rectum, V65 post PET

Rectum Dosimetric Endpoints

Bladder, V40 pre-PET

Bladder, V40 post-PET

Bladder, V65 pre-PET

Bladder, V65 post-PET

Bladder Dosimetric Endpoints

Number of patients with Acute GU toxicity

Number of patients with Late GU toxicity

All patients in both the FACBC PET scan and the Conventional-imaging only groups.

Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity

Number of patients with Acute GI toxicity

Number of patients with Late GI toxicity

Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity

EPIC GU-incontinence domain score

EPIC GU - irritative/obstructive

Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.

FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.

Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.

Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score

Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score

Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score

Expanded Prostate Cancer Index Composite (EPIC) Total Score

Overall Study

Symptoms and General Pathology

Recurrence

Carcinoma

Disease Attributes

Participants receiving a bolus of anti-\[18F\]FACBC injected with PET-CT detection of cancer recurrence.

Participants will receive a bolus of anti-\[18F\]FACBC injected IV over 1-2 minutes. The dosage will be approximately 10.0 millicuries (mCi) (3.70 x 108 becquerel (Bq)).

The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate.

Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy. Significant advances have been made which have improved the cancer control outcomes and treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent (returning) disease usually displays rising Prostate-Specific Antigen (PSA) (a blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (i.e. recurrence in the prostate bed) from recurrence outside of the prostate bed (extra-prostatic recurrence). Imaging plays a central role in the detection of recurrent prostate carcinoma in the prostate bed and in the differentiation of prostatic from extraprostatic recurrence. There are newer methods of imaging such as magnetic resonance imaging (MRI) and positron emission tomography (PET) with molecular radiotracers that are currently under study for the imaging of post-therapy recurrence.

One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3-\[18F\]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with other methods in the restaging of patients with suspected recurrent prostate carcinoma. FACBC has been tested in over 140 subjects in other studies in the Emory system including 128 subjects with prostate cancer.

The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA.

All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate. Biopsy of the suspected recurrence sites will be scheduled at the subjects' convenience as soon as possible after the scans.

Tissue obtained from the biopsy will undergo standard analysis to determine if prostate carcinoma cells are present. The secondary aim is to use left-over biopsy material to determine if there are genotypic differences between prostate carcinoma recurrence confined to the prostate bed and extraprostatic recurrence

FACBC for Recurrent Prostate Cancer

Transmolecular Imaging of Recurrent Prostate Carcinoma With Exploration of Genomic Markers Differences Between Local and Distant Recurrence

Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:

1. = definitely benign
2. = probably benign
3. = equivocal
4. = probably malignant
5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease.

David M. Schuster, MD

Participants receiving a bolus of anti-\[18F\]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence.

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

PET-MR Interval

Brachytherapy alone

Brachytherapy with one

Brachytherapy as part of 3+ treatments

Radiotherapy alone

3+ Other Treatment Modalities

Proton Therapy

Cryotherapy alone

Cryotherapy plus hormonal therapy

Prior prostate cancer therapy

Prostate-Specific Antigen (PSA)

Participants completing both scans are included in the baseline analysis.

David Schuster MD

PET-CT Readers 1 and 2

mpMR Reader 1

mpMR Reader 2

The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (22 out of 24 participants who received both scans). The remaining two had no biopsy or had insufficient follow-up information to reach a consensus about disease status.

The Presence of Cancer Tissue Inside of the Prostate Bed

The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (18 out of 24 participants who received both scans).

The Presence of Cancer Tissue Outside of the Prostate Bed

Participants receiving a bolus of anti-\[18F\]FACBC injected with positron emission tomography (PET)-computerized tomography (CT) (PET-CT) and a multiparametric MRI (mpMR) for detection of cancer recurrence.

Skin and Connective Tissue Diseases

Breast Neoplasms

Drug FACBC will be given intravenously (IV) over 2 minutes prior to performing the PET scan

Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in 2010 leading to 39,840 cancer related deaths.

Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has become the a standard method for isolating the tumor. However, FDG is insensitive in small breast tumors and certain histologic types such as lobular, certain types of breast carcinoma. In addition, FDG uptake can be nonspecific since inflammatory some benign lesions may also evidence have accumulation of this radiotracer. Hence there is a need for a tracer/imaging tool that increases the ability to characterize detect breast carcinoma and to detect locoregional spread, as well as monitor therapeutic treatment response.

anti-3-\[18F\]. anti-1-amino-3-\[18F\]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments,FACBC has shown uptake in the breast tumor cell line.

The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics via time-activity curves from dynamic imaging characteristics. The investigators will enroll 12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care imaging as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The investigators will then compare findings to determine if this radiotracer is worthy of further study in a more comprehensive experiment.

Anti-1-amino-3-[18F]Fluorocyclobutyl-1-carboxylic Acid (Anti-[18F](FACBC)Positron Emission Tomography (PET-CT) of the Breast

Amino Acid Transport Imaging of Breast Carcinoma Via Anti-3-[18F]FACBC PET-CT: A Pilot Study

Sponsor-Investigator

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT.

Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan

ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.

ProstaScinct

Hypothesis:Anti-\[18F\]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients.

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called \[18\]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called \[18\]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done.

Anti-\[18F\]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention.

This study will look at how the \[18\]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.

FACBC PET/CT for Recurrent Prostate Cancer

18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).

Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.

Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.

Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.

Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.

Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.

Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.

Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.

Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.

1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. \[total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)\]
2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. \[ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)\]
3. Accuracy = (True positives + true negatives)/all tests
4. Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
5. Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed

1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
3. Accuracy = (True positives + true negatives)/all tests
4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed

1. Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
2. Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
3. Accuracy = (True positives + true negatives)/all tests
4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed

1. Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. \[total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)\]
2. Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. \[ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)\]
3. Accuracy = (True positives + true negatives)/all tests
4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
5. Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed

All participants who received scans, including repeat scans, were monitored for adverse events.

FACBC PET-CT and ProstaScint CT

Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.

Participants completed both the FACBC PET-CT and the ProstaScint CT.

FACBC PET-CT

ProstaScint CT

91 participants had sufficient data to determine disease presence or absence in the prostate bed.

Number of Participants With True Positive Scans Within the Prostate Bed

Number of Participants With False Positive Scans Within the Prostate Bed

Number of Participants With True Negative Scans Within the Prostate Bed

Number of Participants With False Negative Scans Within the Prostate Bed

There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.

Number of Participants With True Positive Scans Outside the Prostate Bed

Number of Participants With True Negative Scans Outside the Prostate Bed

Number of Participants With False Positive Scans Outside the Prostate Bed

Number of Participants With False Negative Scans Outside the Prostate Bed

% Sensitivity

% Specificity

% Accuracy

% Positive Predictive Value

% Negative Predictive Value

This is a single arm study

\[18F\]FACBC: \[18F\]FACBC is given intravenously prior to PET scan

Participants with a definitive consensus for the presence or absence of extraprostatic disease.

Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma

Participants with a definitive consensus on the presence or absence of prostatic/bed disease.

Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed

Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed

Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma

Head and Neck Neoplasms

Ayse Karagulle Kendi, MD

David Schuster, MD

The purpose of this study is to assess a relatively new PET (Positron emission tomography) radiotracer called FACBC in the assessment of head and neck cancer. FDG (Flourine Deoxyglucose) is currently used for PET imaging, but has limitations in head and neck cancer. These limitations include problems with specificity, high background uptake from normal structures, difficulty delineating intracranial invasion, and the need to wait several weeks after chemotherapy and radiation before imaging. As an amino acid radiotracer, rather than a glucose radiotracer, FACBC overcomes some of these limitations. FACBC does not yet have FDA (Food and Drug Administration) approval, but does show promise in initial work in patients with prostate cancer and brain tumors. Dosimetry work on FACBC has been performed at Emory.

Our study is a pilot study looking at 10 patients with a new diagnosis of biopsy proven squamous cell carcinoma of the oral cavity who will be able to go on to definitive surgical resection (ie, surgery without preceding chemotherapy or radiation). Patients must have pre-surgical imaging, either with a contrast enhanced CT, FDG PET, or MRI. Patients who consent to participate will receive one FACBC PET/CT of the neck, which will require a low dose "transmission" CT of the neck, an intravenous injection of the radiotracer, and imaging of the neck that will last up to 1 hour. Patients will have to lie still during the imaging time. Total participation time including set up should be less than 90 minutes. Imaging results will be analyzed and compared with conventional imaging as well as the surgical pathology results

FACBC for Head and Neck Cancers

Initial Evaluation of Anti-1-amino-F-18 Flurocyclobutane-1carboxylic Acid (Anti-18F-FACBC) in the Assessment of Head and Neck Cancer: A Pilot Study.

The results of the FACBC PET scan will be validated by direct comparison with the pathology findings obtained at surgery. .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FACBC Outcomes for Post Prostatectomy	NCT01666808	Prostate Cancer	FACBC Radiation thera...	18 Years - 95 Years	Emory University
FACBC for Recurrent Prostate Cancer	NCT01808222	Recurrent Prost...	FACBC	18 Years -	Emory University
Anti-1-amino-3-[18F]Fluorocyclobutyl-1-carboxylic Acid (Anti-[18F](FACBC)Positron Emission Tomography (PET-CT) of the Breast	NCT01659645	Breast Cancer	FACBC	18 Years - 85 Years	Emory University
FACBC Outcomes for Post Prostatectomy	NCT01666808	Prostate Cancer	FACBC Radiation thera...	18 Years - 95 Years	Emory University
FACBC PET/CT for Recurrent Prostate Cancer	NCT00562315	Prostate Cancer	FACBC ProstaScinct	18 Years -	Emory University
FACBC for Head and Neck Cancers	NCT01933269	Cancers of the ...	FACBC	18 Years -	Emory University
FACBC for Recurrent Prostate Cancer	NCT01808222	Recurrent Prost...	FACBC	18 Years -	Emory University

Spots Global Cancer Trial Database for facbc

Every month we try and update this database with for facbc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for facbc

Every month we try and update this database with for facbc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for facbc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.