Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Adjuvants, Anesthesia

Anticonvulsants

Antiemetics

Central Nervous System Depressants

Muscle Relaxants, Central

Psychotropic Drugs

Gastrointestinal Agents

All Drugs and Chemicals

Diazepam

Breast biopsy using PEM guidance and Stereo Navigator software

PEM Breast Biopsy

Mary C Mahoney, MD

Amy Argus, MD

The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.

Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer

Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer

University of Cincinnati

Professor, Director of Breast Imaging

PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software

Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy.

Primary

Women 25 years of age or older with a highly suspicious breast mass recommended to biopsy.

Age, Categorical

Sex: Female, Male

Mary Mahoney, MD

Index Lesioins

Index Lesions Visualized at PEM

Additional Lesions seen only at PEM

Lesions technically adequate for targeting

Number of Lesions Biopsied

Total lesions visualized using positron emission mammography.

Lesions Visualized Using Positron Emission Mammography (PEM)

Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.

Overall Study

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

For patients with suspicious breast abnormalities seen on high resolution PET image, the patients will be biopsied using commercial vacuum biopsy devices (pre-validated to work with Stereo Navigator) using Naviscan's Stereo Navigator (interventional device) for PET image guidance.

Stereo Navigator Accessory to PEM Flex PET Scanner

Judith E Kalinyak, MD, Ph.D

The purpose of this pilot clinical study is to test a methodology for using high-resolution Positron Emission Tomography (PET) imaging to guide vacuum-assisted core biopsy of breast abnormalities identified on PET. In order to implement the PET guidance, the study uses the Stereo Navigator accessory to the high-resolution organ-specific PET scanner (PEM Flex™ PET Scanner, Naviscan PET Systems, Inc., San Diego, CA). The Stereo Navigator is an investigational device intended for guiding biopsy needles toward lesions in breasts identified by a physician on a high resolution PET image. The study will evaluate the clinical utility of the Stereo Navigator in guiding the vacuum-assisted core biopsy of breast abnormalities, following the example of prior studies of breast biopsy guided by magnetic resonance imaging (MRI)

The study will invite participation from human subjects with newly diagnosed or suspected breast cancer who have one or more breast abnormalities moderately suspicious or highly suggestive of malignancy on breast imaging and requiring biopsy (the lesion(s) of interest). Prospective subjects will be asked to sign IRB-approved consent forms, explaining the use of PET imaging for guiding biopsy of suspicious lesion(s). Up to 30 patients will be recruited in the study. The study will be terminated after approximately 20 subjects undergo PET-guided interventional procedures. In the course of the study, a subject will be injected with 18F-FDG and imaged using the PEM Flex PET scanner. Once an abnormality requiring biopsy is identified on the PET scan, the physician conducting the procedure will use the PET image to plan the biopsy trajectory using the Stereo Navigator Software Module, and use the Stereo Navigator Needle Guide Holder to guide insertion of the introducing stylet toward the lesion. The sampling will be performed using commercially available core biopsy tools routinely used for MRI-guided biopsy.Immediately after the PET-guided biopsy, conventional biopsy markers will be inserted at the biopsy site(s) for correlation with other imaging modalities. Placement of the biopsy marker will be documented using mammography, as per standard clinical practice. Histopathologic results will be correlated with imaging findings. The procedure may be repeated for additional lesions identified on PET at the investigator's discretion.

Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities

Pilot Clinical Study to Evaluate High Resolution PET Imaging- Guidance for Sampling of Breast Abnormalities in Patients With Known or Suspected Breast Cancer

Participants who could tolerate the procedure and complete it. This was ascertained by patient feedback questionnaire asking for overall discomfort rating from 0 to 5, where 0 is no discomfort and 5 was assigned to acute discomfort that prevented subject from completing the procedure.

Success in completion of the PET guided biopsy of a suspicious lesion was determined by

1. Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR
2. Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent).

Serious Adverse Events are defined as events that

* Are fatal or life-threatening
* Require in-patient hospitalization or prolong hospitalization
* Result in permanent or significant disability/incapacity
* Result in congenital abnormality/birth defect

American Radiology Services, Inc

Boca Raton community Hospital, FL

Diversified Specialty Institutes, Bensalem, PA

Advanced Breast Care Imaging

Epic Imaging

Naviscan PET Systems

Judith Kalinyak, MD. Ph.D, Medical Director

No comparison group. All enrolled participants were expected to undergo PET guided biopsy.

PET Guided Biopsy

Age Continuous

United States

Region of Enrollment

Judith E Kalinyak, MD, PhD, Medical Director

All participants who completed the PET-guided biopsy for a suspicious lesions. 24 lesions were biopsied in 19 participants

Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.

Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy

Number of Participants Who Tolerated the PET-Guided Biopsy Procedure

Fluorodeoxyglucose F18

All consenting patients who are to have staging breast MRI, will be offered 18FDG PEM (Positron Emission Mammography) within 30 days. If the patient had a previous breast MRI that was done within 30 days at an outside institution, this MRI can be used if a radiologist determines that it is an adequate study. The surgery date will not be affected by the additional PEM evaluation. All imaging will be done and reviewed by MSKCC breast imagers. MRI and PEM findings suggestive of malignancy will be prospectively recorded in both the ipsilateral and contralateral breast.

An additional 5 women will be enrolled at the beginning of the study for training purposes only and will not be included in the assessment of this study. Once the patient has had both breast MRI and PEM, the location of each site of potential breast cancer will be listed for each modality. The location of each abnormality on each imaging examination will be documented. Once the histopathologic evaluation has been performed, the pathology results will be compared to the imaging results for each modality. Furthermore, comparison of the performance of MRI and PEM will then be made with the pathological results as the truth. Comparison of the histology and biomarkers in each lesion detected by each modality will be done in order to determine if these factors affect detection by each modality.

Positron Emission Mammography (PEM) and Magnetic Resonance Imaging (MRI)

Maxine Jochelson, MD

Positron Emission Mammography (PEM) is a newly developed imaging examination of the breast that uses a radioactive glucose based tracer, which is a form of sugar attached to a low radiation agent, to detect cancer cells. The radioactive glucose based tracer is called fluorodeoxyglucose (FDG), and it is FDA approved. A PEM scanner is able to better detect cancer cells within the breast, more than a regular PET scanner. The PEM scanner is also FDA approved. This type of imaging may be able to see the breast cancer before it could be seen with mammograms and may be as good as or better than breast MRI.

The purpose of this study is to compare the value of FDG Positron Emission Mammography (PEM) with contrast enhanced Magnetic Resonance Imaging (MRI) of the breast for patients with breast cancer. This study will also perform special pathology test to compare the FDG PEM and contrast enhanced breast MRI images with the results from the standard of care breast surgery. This may teach us more about the biology of each breast tumor.

Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast

using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.

Memorial Sloan Kettering Cancer Center

Female patients with recently diagnosed invasive or in situ breast cancer

Preoperative 18FDG PEM and MRI

Female patients with recently diagnosed invasive or in situ breast cancer.The first 5 patients who consent to the study will be intended for training purposes only.

The first 5 patients who consent to the study will be intended for training purposes only.

The first 5 patients who consent to the study were used for training purposes only.

Dr. Maxine Jochelson

No data displayed because Outcome Measure has zero total participants analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer	NCT00981812	Breast Cancer	PEM Breast Biop...	25 Years -	University of Cincinnati
Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities	NCT00606931	Breast Cancer	Stereo Navigato...	25 Years -	Naviscan PET Systems
Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast	NCT01249157	Breast Cancer	Positron Emissi...	21 Years -	Memorial Sloan Kettering Cancer Center
Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast	NCT01249157	Breast Cancer	Positron Emissi...	21 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for pem

Every month we try and update this database with for pem 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 pem

Every month we try and update this database with for pem 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 pem 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.