Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Fluorides

18F-fluorocholine

Yu-Hung Chen, M.D.

Prostate cancer remains to be a public health problem around the world. For patients with prostate cancer, diphosphonate bone scintigraphy (BS) and pelvic tomographic imaging are major imaging tools to evaluate the disease spread. However, the conventional image modalities have only limited sensitivity and specificity. New imaging tracer with 18F-fluorocholine (18F-FCH) and old radiopharmaceuticals with NaF has showed promising results in detecting prostate cancers over bone scan. Nevertheless, the diagnostic performance of each tool has less been compared.

The goal of this study is to compare the diagnostic performance of 18F-FCH PET/CT and NaF PET/CT for prostate cancer patients.

The investigators prospectively enroll patients with the pathological diagnosis of prostate cancer and intended to receive radionuclide bone image. The patients will receive NaF PET/CT and 18F-FCH PET/CT. Each image will be evaluated by experienced interpreter for abnormal uptake suspicious for cancer spreading. The reference standard will be a combination of tissue correlation, imaging, laboratory and clinical data. Diagnostic performance of both PET/CT scans will be measured and calculated.

The investigators conducted a prospective study to investigate the performance of 18F-choline (FCH) PET/CT and 18F-NaF PET in the patients with prostate adenocarcinoma.

18F-NaF PET imaging protocol: Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).

An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 18F-NaF (148 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. NaF PET/CT scan acquisition is to be taken 30 minutes after radiotracer injection. The PET/CT (120 mA, 120 kVp) scan field will cover from vertex to toe.

Image analysis: Two nuclear medicine physicians assess the NaF PET/CT images. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. Uptake in the focus will be evaluated of the likelihood of cancer in 5-graded scale. 0. No cancer or definitely no pathologic aspect; 1. Probably benign lesion; 2. Equivocal lesion; 3. Probably cancer; 4. Most probably cancer. For the determination of a diagnosis, score 0 and 1 are considered a negative result and 2 to 4 a positive result.

18F-FCH PET imaging protocol: The 18F-FCH PET will be arranged within 6 weeks after NaF PET. Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).

An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 18F-FCH (185 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. The injected 18F-FCH dose, injection time, post-injection residual activity, time of start imaging and time of end imaging will be recorded on case report form. 18F-FCH PET/CT scan acquisition is to be taken 5 to 10 minutes after radiotracer injection. The PET/CT (80-120 mA, 120 kVp) scan field will cover from skull to mid-thigh. The 18F-FCH PET/CT scan time will require 35-40 minutes.

Image analysis: Two nuclear medicine physicians assess the 18F-FCH PET/CT images. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. Uptake in the focus will be evaluated of the likelihood of cancer in 5-graded scale. 0. No cancer or definitely no pathologic aspect; 1. Probably benign lesion; 2. Equivocal lesion; 3. Probably cancer; 4. Most probably cancer. For the determination of a diagnosis, score 0 and 1 are considered a negative result and 2 to 4 a positive result.

Reference standard: The skeletal lesion will be evaluated by both 18F-FCH PET/CT and NaF PET/CT findings. Congruent positive lesion and congruent negative will be defined as true positive and true negative, respectively. A third image study (MRI or CT) will be introduced for those with incongruent and ambiguous PET features. Biopsy will be reserved for those lesions with undetermined results after third image study.

The extra-skeletal cancerous lesions are theoretically be detected on 18F-FCH PET/CT only, thus, the reference modality will not include NaF PET/CT. The prostate bed in patients with either positive or negative imaging studies will be investigated with pelvic MRI. Patients with abnormal foci in pelvic and abdominal extraprostatic tissue at imaging will be investigated by using pelvic MRI as well. If lesions on MRI and 18F-FCH PET/CT are both positive, the lesions will be treated as malignancy. Patients with lesions on 18F-FCH PET/CT along will be evaluated by the investigator and co-investigators to decide if the patient will receive biopsy or not. The lesion will be confirmed to be malignant if positive biopsy results. The patient will receive further follow-up by MRI and serum PSA after 6 and 12 months if the patient is not suitable for biopsy. The lesion will be confirmed to be malignant if substantial growth in lesion size or increase serum PSA. Patients with both negative MRI and negative 18F-FCH PET/CT will be evaluated by the aforementioned follow-up schedule as well. If the initial pelvic MRI is positive for malignancy and the 18F-FCH PET/CT is negative, the lesion will be treated as positive for malignancy. However, the patient still need the 6 and 12 months of follow-up to confirm the nature of the lesion. Biopsy will be reserved for those patients with undetermined results despite vigorous image studies.

The patients will receive both 18F-fluorocholine PET and NaF PET

18F-fluorocholine and 18F-fluoride PET in Prostate Cancer

Comparative Evaluation of Metastatic Lesions From Prostate Carcinoma With 18F-NaF and 18F-Fluorocholine PET/CT

The lesion-based sensitivities of these two image modalities (The number of true positive image findings/The number of confirmed metastasis)

The lesion-based specificities of these two image modalities (The number of true negative image findings/The number of confirmed e benign lesion)

To calculated the extraskeletal metastatic lesion that is detected by 18F-fluorocholine PET/CT

Buddhist Tzu Chi General Hospital

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Hyperplasia

Breast Diseases

Skin Diseases

Menopause

Hormones

Carol J Fabian, MD

To examine nipple aspirate fluid for secretions that may be identified as a high risk indicator for development of breast cancer, and compare those to serum analysis.

To examine nipple aspirate fluid analysis in lactating women for local concentration of estrogen, prolactin, glucocorticoids, insulin, parity, prior lactation and age. NAF secretors have been reported to have modest increase in breast cancer risk compared to non-secretors . Estrogen levels have been found to be markedly higher in NAF samples than in the serum collected from the same women. Estradiol and estrone concentrations in premenopausal women are 10x and 20x greater in NAF samples than in serum and 50x and 35x greater in post-menopausal women not on HRT. It has been suggested that the disparity between serum and NAF levels may be due to local estrogen production via aromatase and sulfatase.

Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Study of Manual Nipple Fluid Aspiration IN Post-Menopausal Women

Carol Fabian, MD

Professor, Director Breast Cancer Prevention Unit

This group will be evaluated for marker presence in NAF. no drugs administered

This group will be evaluated to study whether marker(s) detected in NAF are also expressed in non-cancerous tumors. No drugs administered

In this group, any markers detected in NAF could also be detected in tumor tissues. No drugs administered.

This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically detectable tumors, and those who have detectable tumors, 2) identify all the detectable markers and 3) establish that biomarkers detected in NAF could also be detected in the biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
18F-fluorocholine and 18F-fluoride PET in Prostate Cancer	NCT04340765	Prostate Cancer Fluorocholine	18F-fluorocholi...	20 Years -	Buddhist Tzu Chi General Hospital
Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer	NCT00291083	Breast Cancer		18 Years -	University of Kansas Medical Center
Biomarker Breast Pap Test	NCT01683305	Tumors		18 Years -	Silbiotech
Biomarker Breast Pap Test	NCT01683305	Tumors		18 Years -	Silbiotech

Spots Global Cancer Trial Database for naf

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

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