18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy

NCT04018053 | Active Not Recruiting Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 19-208
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer; Urothelial Carcinoma

Keywords

Bladder cancer; urothelial carcinoma; cystectomy

Outcome Measures

Primary Outcomes (1)

• The Agreement Rate of Metastatic Disease Status Between 18F-fluciclovine-PET/CT and Histopathology From 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.

  2 years

Secondary Outcomes (3)

• The Amount of 18F-fluciclovine Accumulation in the Primary Bladder Tumor on PET

  2 years

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

  2 years

• 18F-fluciclovine Uptake on PET/CT to the Presence/Absence of ASCT2 and LAT1 Amino Acid Transporters.

  2 Years

Study Arms (1)

18F-fluciclovine

EXPERIMENTAL

* 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-fluciclovine; Device: PET/CT

Interventions

18F-fluciclovine DRUG

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

Also known as: Axumin

18F-fluciclovine

PET/CT DEVICE

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.

18F-fluciclovine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or cytologically confirmed urothelial carcinoma of the bladder.
• Participants must have cT2-T4N0 disease at the time of the study, as defined by conventional CT or MRI imaging. Patients must have no definite evidence of locoregional or distant metastatic disease at the time of study eligibility, as defined by conventional imaging.
• Radical cystectomy must be planned for the patient after the planned 18F-fluciclovine-PET/CT.
• Patients may or may not have had prior neoadjuvant therapy prior to this study.
• Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants \<18 years of age, and the majority of bladder cancer occur in the adult population \[42\], children are excluded from this study but will be eligible for future pediatric trials.
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
• Ability and willingness to comply with the study procedures.
• The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is completed. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Participants with other known malignancies that has required treatment in the past 3 years.
• Pregnant women are excluded from this study because 18F-fluciclovine is a radiopharmaceutical with the potential for teratogenic effects. Because of the radiation exposure to a nursing infant from 18F-fluciclovine, women who are breastfeeding are also excluded from this study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Contraindications for PET/CT including:
• Severe claustrophobia
• Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Ng TSC, Liu M, Robertson M, Konik A, Cheng SC, Bakht MK, Harrington K, Wolanski A, Gilbert L, Preston M, Mossanen M, Beltran H, Hirsch MS, Sonpavde G, Jacene HA. A pilot study of [18F]F-fluciclovine positron emission tomography/computed tomography for staging muscle invasive bladder cancer preceding radical cystectomy. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4092-4101. doi: 10.1007/s00259-025-07287-y. Epub 2025 Apr 21.

  PMID: 40257614 BACKGROUND

Related Links

• Link to pubmed citation

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Interventions

fluciclovine F-18; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Heather Jacene
• Organization: BrighamHospital

hjacene@bwh.harvard.edu

617-632-3767

Study Officials

• Heather Jacene, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: February 26, 2020
• Primary Completion: June 30, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 27, 2026
• Results First Posted: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)