18F-fluciclovine for Urinary Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MA
Urinary Bladder Cancer+3 More
18F-fluciclovine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a PET scan can help determine the extent of muscle invasive bladder cancer.

See full description

Eligible Conditions

  • Urinary Bladder Cancer
  • Transitional Cell, Carcinoma
  • Bladder Cancer, Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Urinary Bladder Cancer

Study Objectives

This trial is evaluating whether 18F-fluciclovine will improve 1 primary outcome and 3 secondary outcomes in patients with Urinary Bladder Cancer. Measurement will happen over the course of 2 years.

2 Years
18F-fluciclovine uptake on PET/CT to the presence/absence of ASCT2 and LAT1 amino acid transporters.
2 years
The agreement rate of metastatic disease status between 18F-fluciclovine-PET/CT and histopathology from radical cystectomy
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 Safety

Safety Progress

1 of 3

Other trials for Urinary Bladder Cancer

Trial Design

1 Treatment Group

18F-fluciclovine
1 of 1
Experimental Treatment

This trial requires 16 total participants across 1 different treatment group

This trial involves a single treatment. 18F-fluciclovine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

18F-fluciclovine18F-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
Fluciclovine (18F)
FDA approved
PET/CT
2020
Completed Phase 3
~1060

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
H. A. J.
Heather A. Jacene, Principal Investigator
Dana-Farber Cancer Institute

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Urinary Bladder Cancer or one of the other 3 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What causes carcinoma, transitional cell?

"The cause of carcinoma, TCC remains a mystery, though it is probably related to certain environmental elements and possibly other factors. It is probable that carcinoma, TCC is caused by complex interaction of genetic, environmental, hormonal and other factors." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, transitional cell a year in the United States?

"The incidence of this malignancy, unlike cervical malignancies among both men and women, will fall in the next forty years, a decline that could offset any increase in incidence for cervical malignancies among white women." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, transitional cell be cured?

"Transitional cell carcinoma of the bladder generally cannot be cured due to a high recurrent rate and a low cure rate. The highest cure rate has been reported for TCC of the bladder confined to the bladder." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, transitional cell?

"Symptoms of endometriosis include pelvic pain, bleeding from the vagina, infertility and abnormal bleeding or spotting after menopause.\n\nSymptoms of cancer of the breast\nNote: Symptoms of breast cancer vary depending on the location of the primary tumor. Lymph nodes may become swollen with adhesions and in the axillary area may become tender and hard to palpate. Some breast cancers may also cause lymphedema. \n\nSymptoms of cancer of the pancreas\nNote: Symptoms of pancreatic cancer vary depending on the location of the primary tumor. Most of the symptoms appear gradual over months to years. Lymph nodes around or in the abdomen may become enlarged." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, transitional cell?

"Carcinoma, transitional cell of the bladder is the third most common bladder tumor (0.14% of the population will have had such a tumor). In more than half of cases, the tumor is detected by the symptoms of hematuria, frequent urination or pain over the course of weeks or months. It usually progresses slowly and metastasizes by way of the vascular system only to a limited and usually peripheral part of the urinary bladder. The prognosis is determined by the stage of the cancer, the type of treatment given, the underlying type of bladder cancer (transitional cell carcinoma) and the individual tumor markers. The majority of patients treated with surgery will have a five-year survival of 80-95%." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, transitional cell?

"There are many forms of treatment, including surgery, chemotherapy, radiation therapy, targeted therapy, and chemoradiation. These treatments are tailored to the condition of the patient, however, most of them have the same goal—to prolong life." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, transitional cell spread?

"The speed of carcinoma, transitional cell spread appears to be related to the aggressiveness of carcinoma, transitional cell cancer as well as the amount of spread of carcinoma, transitional cell cancer at the time of initial diagnosis." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, transitional cell?

"There are not enough [cancer trials for transitional cell and bladder cancer] (https://www.hss.edu/ConditionList/BladderCarcinoma%20Transitional%20Cell%20Kidney%20Treatment_Cancer_Trial.aspx). Patients need to be informed that some therapeutic options are ineffective for either bladder or transitional cell cancers as only small study samples remain in clinical trials. In addition, there are no data to be based on. Power to help you find trials tailored to your treatment." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of 18f-fluciclovine?

"The common side effects during treatment with (18)F-FDG are similar to those produced by other 18F-labeled FDG analogues, namely nausea, fatigue, malaise, loss of appetite, headache, vomiting, urinary incontinence, and loss of appetite. The number and severity of adverse effects is higher in patients treated with (18)F-FDG compared to patients treated with (11)C-methionine-dextroamphetamine (MDR2-INVIBEM) in a prospective trial of MDR2-defined MDR2-positive patients." - Anonymous Online Contributor

Unverified Answer

Has 18f-fluciclovine proven to be more effective than a placebo?

"18F-FL will be a useful agent to use with patients who have received prior radiotherapy to evaluate disease recurrence, and in future it may prove to be more effective for imaging purposes than its sibling, 18F-FDG." - Anonymous Online Contributor

Unverified Answer

What does 18f-fluciclovine usually treat?

"F-18FLV has been reported to be useful for the detection of tumor and inflammation in various areas. It is also used as a tracer in the study of the brain, prostate, esophagus, kidney, and liver." - Anonymous Online Contributor

Unverified Answer

How does 18f-fluciclovine work?

"(18)F)F-fluciclovine PET is a rapid and reliable tool for functional imaging of the [F]-labeled adhesion molecule MUC18, known to overexpress at high levels in bladder cancer, at tumors that bear overexpression of MUC18, and within a subset of bladder tumors with minimal staining for MUC18. A potential role, as an indicator of tissue aggressiveness, or as a biomarker for evaluating the effects of anticancer therapeutics or therapies blocking MUC18 may warrant further study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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