CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 16 enrolled / 16 target
Drug / intervention
18F-fluciclovine +1 moredrug
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/NCT04018053
NCT04018053Early Ph 1CompletedUpdate Overdue (0.2/mo)Completion was 24mo ago
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A Pilot Study of 18Fluorine-Fluciclovine Positron Emission Tomography/Computed Tomography for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy

Brigham and Women's Hospital·interventional·Posted Jul 12, 2019·Updated Jun 24, 2026

In Brief

A Early Phase 1 clinical trial evaluating 18F-fluciclovine and PET/CT for Bladder Cancer and Urothelial Carcinoma. Completed, enrolled 16 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of muscle invasive bladder cancer (as compared to regular CT and MRI imaging) and whether 18F-fluciclovine-PET scans can provide information about the pathologic grade of the tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer, Urothelial Carcinoma
CountriesUnited States
CollaboratorsBlue Earth Diagnostics

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedJul 12, 2019
Enrollment StartFeb 26, 2020
Primary CompletionJun 30, 2024
Study CompletionSep 25, 2025
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.0 years ago

Arms & Interventions

18F-fluciclovineexperimental

* 18F-fluciclovine will be administered via slow push over 10 seconds through a peripheral intravenous line * Immediately after the injection of the radiopharmaceutical, dynamic PET/CT images of the pelvis will be obtained for 15 minutes * Subsequently, PET/CT images will be obtained from the pelvis to the base of skull.

Drug: 18F-fluciclovineDevice: PET/CT

Interventions

18F-fluciclovinedrug

18F-fluciclovine is a new radiotracer. This radiotracer targets amino-acid transporters, which are overexpressed in multiple cancers.

PET/CTdevice

Positron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.