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 Information
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 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
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
Administrative Informations
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
July 2021