New scan could sharpen bladder cancer staging
NCT ID NCT04018053
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested whether a new radioactive tracer called 18F-fluciclovine, used with a PET/CT scan, can better determine the extent of muscle invasive bladder cancer before surgery. Sixteen participants with bladder cancer received the tracer and scan before their planned bladder removal. The goal was to see if the scan could more accurately detect cancer spread compared to standard CT or MRI scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-fluciclovine (a radioactive tracer used in PET scans)
- What this could lead to
- If successful, this could lead to more accurate staging of bladder cancer, helping doctors choose the best treatment and avoid unnecessary surgery.
- What could go wrong
- This is a very early, small pilot study with only 16 participants. The tracer may not prove more accurate than current methods, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
16 people
The number who actually took part.
- Started
-
Feb 2020
- Finished
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Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Bladder-Sparing hope: cystoscopy tested to spot Cancer-Free bladders before surgery
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- Can intensified chemotherapy before surgery clear bladder tumors?
- Lab-Grown tumor organoids could pick the right bladder chemo
- Chemo combo tested as backup for bladder cancer that outsmarts First-Line therapy