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BRIEF TITLE: Study of 18Fluorine-Fluciclovine Positron Emission Tomography/Computed Tomography for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy

A Pilot Study of 18Fluorine-Fluciclovine Positron Emission Tomography/Computed Tomography for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy

  • Org Study ID: 19-208
  • Secondary ID:
  • NCT ID: NCT04018053
  • NCT Alias:
  • Sponsor: Dana-Farber Cancer Institute - Other
  • Source: Dana-Farber Cancer Institute

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.

Detailed Description

This research study is a pilot study, which is the first-time investigators are examining
this study imaging agent, 18F-fluciclovine, for use in imaging bladder cancer.

Staging of muscle invasive bladder cancer is currently done using computed tomography (CT)
and/or magnetic resonance imaging (MRI). Both CT and MRI are useful to determine the extent
of bladder cancer, but some studies show that up to 40% of patients with negative CT or MRI
scans for disease outside the bladder are found to have disease outside the bladder (in lymph
nodes near the bladder) at the time of surgery.

Given the limitations of the imaging exams currently used for staging bladder cancer, new
techniques and imaging agents that can better identify metastatic lesions, especially within
the pelvis, are desired and would be very useful.

18F-fluciclovine is a new radiotracer that was recently approved to evaluate lesions in
recurrent prostate cancer (but not for bladder cancer). This radiotracer targets amino-acid
receptors, which are overexpressed in multiple cancers. Studies have shown that
18F-fluciclovine PET/CT can visualize other types of cancers, such as breast cancer. A major
advantage of 18F-fluciclovine is that it does not get into the bladder during the time of
imaging. This may make it easier to see disease in the pelvis that is outside the bladder.

The purpose of this study to determine whether 18F-fluciclovine PET/CT can better stage
muscle invasive bladder cancer compared to conventional CT or MRI. A secondary aim of this
study is to determine whether 18F-fluciclovine PET/CT can reveal the pathologic grade of the
bladder cancer, which is only determined from pathology specimens obtained at surgery.

Overal Status Start Date Phase Study Type
Recruiting February 26, 2020 Early Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: The agreement rate of metastatic disease status between 18F-fluciclovine-PET/CT and histopathology from radical cystectomy

Primary Outcome 1 - Time Frame: 2 years


  • Bladder Cancer
  • Urothelial Carcinoma


Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- Participants with other known malignancies.

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Heather Jacene, MD

Role: Principal Investigator

Affiliation: Dana-Farber Cancer Institute

Overall Contact

Name: Heather Jacene, MD

Phone: 617-632-3767



Facility Status Contact
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Recruiting Heather Jacene, MD