Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01815515|
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer||Drug: 18F-DCFBC||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer.|
|Actual Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||November 18, 2015|
Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA).
A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.
Other Name: N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-18F-fluorobenzyl-L-cysteine
- Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) [ Time Frame: 24 Months ]Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.
- Sensitivity of Detection of New or Progression of Metastasis [ Time Frame: up to 1 year ]Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where "equivocal" lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815515
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Zsolt Szabo, M.D||Johns Hopkins University|