Trial Outcomes & Findings for 18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy (NCT NCT04018053)
NCT ID: NCT04018053
Last Updated: 2026-06-24
Results Overview
Lymph nodes will be classified as positive or negative for metastatic disease on 18F-fluciclovine PET/CT and compared to pathologic stage as determined from surgery.
COMPLETED
EARLY_PHASE1
16 participants
Single session from 18F-fluciclovine PET/CT scan and single session results from pathology at radical cystectomy, up to 24 hours.
2026-06-24
Participant Flow
The first patient consented and enrolled on 2/26/2020 until 11/2023.
Participant milestones
| Measure |
18F-fluciclovine
* 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.
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|---|---|
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Overall Study
STARTED
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16
|
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
18F-fluciclovine
n=16 Participants
Major eligibility criteria were histologically or cytologically confirmed MIBC, clinical stage T2-T4, N0 disease by CT/MRI at the time of study enrollment, and planned RC. Participants may or may not have had neoadjuvant systemic therapy before enrollment and prior to RC.
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|---|---|
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Age, Continuous
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73 years
n=16 Participants
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Sex: Female, Male
Female
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5 Participants
n=16 Participants
|
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Sex: Female, Male
Male
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11 Participants
n=16 Participants
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Lymph node metastases detection with fluciclovine PET in muscle-invasive bladder cancer
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12 Participants
n=16 Participants
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PRIMARY outcome
Timeframe: Single session from 18F-fluciclovine PET/CT scan and single session results from pathology at radical cystectomy, up to 24 hours.Lymph nodes will be classified as positive or negative for metastatic disease on 18F-fluciclovine PET/CT and compared to pathologic stage as determined from surgery.
Outcome measures
| Measure |
18F-fluciclovine
n=16 Participants
Major eligibility criteria were histologically or cytologically confirmed MIBC, clinical stage T2-T4, N0 disease by CT/MRI at the time of study enrollment, and planned RC. Participants may or may not have had neoadjuvant systemic therapy before enrollment and prior to RC.
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|---|---|
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Agreement Rate of Metastatic Disease Status Between 18F-fluciclovine-PET/CT and Histopathology From Radical Cystectomy
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0.67 proportion scans & pathology that agree
Interval 0.44 to 0.83
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SECONDARY outcome
Timeframe: Time of 18F-fluciclovine PET/CT scan visitPopulation: 13 of the 16 participants had primary bladder tumor in the radical cystectomy specimen. 3 did not have tumor in the specimen and were not able to be evaluated.
18F-fluciclovine Standard Uptake Value in primary bladder tumor as a measure of 18F-fluciclovine accumulation
Outcome measures
| Measure |
18F-fluciclovine
n=13 Participants
Major eligibility criteria were histologically or cytologically confirmed MIBC, clinical stage T2-T4, N0 disease by CT/MRI at the time of study enrollment, and planned RC. Participants may or may not have had neoadjuvant systemic therapy before enrollment and prior to RC.
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Amount of 18F-fluciclovine Accumulation in the Primary Bladder Tumor on PET
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1.90 Standard Uptake Value
Standard Deviation 1.25
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SECONDARY outcome
Timeframe: single session at time of 18F-fluciclovine PET/CT scanVisualization of distant metastases on 18F-fluciclovine-PET/CT will be binary-categorized as present/absent. We will compute sensitivity to compare 18F-fluciclovine-PET/CT with standard imaging modalities for distant metastases. The number of distant metastases will be descriptively shown by imaging modalities.
Outcome measures
| Measure |
18F-fluciclovine
n=16 Participants
Major eligibility criteria were histologically or cytologically confirmed MIBC, clinical stage T2-T4, N0 disease by CT/MRI at the time of study enrollment, and planned RC. Participants may or may not have had neoadjuvant systemic therapy before enrollment and prior to RC.
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|---|---|
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Number of Participants With Suspected Distant Metastatic Disease by 18F-fluciclovine-PET/CT
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0 participants
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Adverse Events
18F-fluciclovine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place