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Fluciclovine PET/CT for Muscle-Invasive Bladder Cancer

Phase < 1
Waitlist Available
Led By Heather Jacene, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new imaging agent to see if it can better detect bladder cancer that has spread to muscle tissue.

Who is the study for?
This trial is for adults over 18 with muscle invasive bladder cancer, who are planning to have their bladder removed (radical cystectomy). They must not be pregnant or breastfeeding, agree to use contraception, and should not have other cancers treated in the last 3 years. Severe claustrophobia or serious illnesses that could interfere with the study are also reasons for exclusion.Check my eligibility
What is being tested?
The study tests a PET scan agent called 18F-fluciclovine against standard CT/MRI scans to see if it's better at showing how far bladder cancer has spread and determining tumor grade before surgery.See study design
What are the potential side effects?
While specific side effects of 18F-fluciclovine aren't detailed here, PET/CT scans may cause discomfort due to lying still for long periods. Allergic reactions might occur but are generally rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a major bladder surgery after a specific PET/CT scan.
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I may or may not have had treatment to shrink my tumor before surgery.
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I can care for myself but may not be able to do active work.
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I am 18 years old or older.
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I agree to use birth control before and 24 hours after my PET/CT scan.
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My cancer is at a stage where it has grown but not spread to lymph nodes.
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My scans show no signs of cancer spread beyond the original site.
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My bladder cancer diagnosis was confirmed through lab tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The agreement rate of metastatic disease status between 18F-fluciclovine-PET/CT and histopathology from radical cystectomy
Secondary outcome measures
18F-fluciclovine uptake on PET/CT to the presence/absence of ASCT2 and LAT1 amino acid transporters.
The amount of 18F-fluciclovine accumulation in the primary bladder tumor on PET
The rate of detection of suspected distant metastatic disease by 18F-fluciclovine-PET/CT

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-fluciclovineExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-fluciclovine
2021
Completed Early Phase 1
~40
PET/CT
2022
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,071 Previous Clinical Trials
340,348 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
3,001 Total Patients Enrolled
Heather Jacene, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
124 Total Patients Enrolled

Media Library

18F-fluciclovine Clinical Trial Eligibility Overview. Trial Name: NCT04018053 — Phase < 1
Bladder Cancer Research Study Groups: 18F-fluciclovine
Bladder Cancer Clinical Trial 2023: 18F-fluciclovine Highlights & Side Effects. Trial Name: NCT04018053 — Phase < 1
18F-fluciclovine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04018053 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being sought for this clinical experiment?

"Indeed, the data posted on clinicaltrials.gov indicates that this medical experiment is currently recruiting participants. It was first made accessible to the public on February 26th 2020 and received its latest update on April 4th 2022; 16 volunteers are needed from a single trial site."

Answered by AI

How many participants are currently being recruited for this clinical experiment?

"Affirmative. Data from clinicaltrials.gov reveals that this medical trial, with its original post date of February 26th 2020, is currently recruiting patients for participation. 16 individuals are needed at one particular site."

Answered by AI

Is this an unprecedented investigation?

"Currently, there are seven ongoing trials for 18F-fluciclovine conducted across 21 cities and one country. These studies began in 2019 when Telix International Pty Ltd sponsored a Phase 2 drug approval process involving 140 individuals. Since then, an additional 21 experiments have been carried out around the world."

Answered by AI

Are there other investigations that have included 18F-fluciclovine in their research?

"Presently, 7 trials are being conducted with 18F-fluciclovine, one of which is in its final phase. Although the majority of studies related to this medication are taking place in Boston, Massachusetts; an additional 28 sites have also been enlisted for research purposes."

Answered by AI
~1 spots leftby Jun 2024