CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
FACBCdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01808222
NCT01808222Phase 2Completed
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Transmolecular Imaging of Recurrent Prostate Carcinoma With Exploration of Genomic Markers Differences Between Local and Distant Recurrence

David M. Schuster, MD·interventional·Posted Mar 11, 2013·Updated Jan 7, 2019

In Brief

A Phase 2 clinical trial evaluating FACBC for Recurrent Prostate Cancer. Completed, enrolled 25 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2013
Enrollment StartNov 1, 2013
Primary CompletionSep 13, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.3 years ago

Interventions

FACBCdrug

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)).