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

Brief Title

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

Official Title

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

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.
    

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 The amount of 18F-fluciclovine accumulation in the primary bladder tumor on PET

Condition

Bladder Cancer

Intervention

18F-fluciclovine

Study Arms / Comparison Groups

 18F-fluciclovine

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

16

Start Date

February 26, 2020

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        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
             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

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Heather Jacene, MD, 617-632-3767, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04018053

Organization ID

19-208

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Blue Earth Diagnostics

Study Sponsor

Heather Jacene, MD, Principal Investigator, Dana-Farber Cancer Institute

Verification Date

March 2021