Trial Outcomes & Findings for 18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy (NCT NCT04018053)

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

EARLY_PHASE1

Target enrollment

16 participants

Primary outcome timeframe

2 years

Results posted on

2026-01-27

Participant Flow

The first patient consented and enrolled on 2/26/2020 until 11/2023.

Participant milestones

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.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

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.
Age, Continuous	73 years n=16 Participants
Sex: Female, Male Female	5 Participants n=16 Participants
Sex: Female, Male Male	11 Participants n=16 Participants
Lymph node metastases detection with fluciclovine PET in muscle-invasive bladder cancer	12 Participants n=16 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 16 patients with muscle-invasive bladder cancer who underwent radical cystectomy; 12 with prior neoadjuvant chemotherapy before radical cystectomy.

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

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.
The Agreement Rate of Metastatic Disease Status Between 18F-fluciclovine-PET/CT and Histopathology From Radical Cystectomy	0.67 proportion of agreement scan and path Interval 0.44 to 0.83

SECONDARY outcome

Timeframe: 2 years

18F-fluciclovine SUVmax in primary bladder tumor as a measure of uptake; primary tumor stage and size at radical cystectomy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Visualization 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

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.
Number of Participants With Suspected Distant Metastatic Disease by 18F-fluciclovine-PET/CT	0 participants

SECONDARY outcome

Timeframe: 2 Years

18F-fluciclovine SUVmax in primary bladder tumor; Presence/absence of ASCT2 and LAT1 amino acid transporter in resected primary bladder tumors

Outcome measures

Outcome data not reported

Adverse Events

18F-fluciclovine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Jacene

BrighamHospital

Phone: 617-632-3767

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place