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hyoscine-n-butylbromide for Ovarian Cancer

Phase 1 & 2
Recruiting
Led By Éric Turcotte, MD
Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to tolerate supine position
Women with a suspected ovarian cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial will use a novel, high-performance tracer to detect hormone-sensitive uterine and ovarian tumors using PET imaging. This could improve the whole-body assessment of those diseases and help clinicians choose the best course of therapy.

Eligible Conditions
  • Ovarian Cancer
  • Endometrial Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You can lie down comfortably on your back.
Select...
You are a woman with suspected ovarian cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare 4FMFES-PET with standard FDG-PET in gynaecological cancers.
Evaluate 4FMFES-PET diagnostic properties in endometrial and ovarian cancers
Use pharmaceutical intervention to slow down peristalsis to improve lower-abdomen 4FMFES-PET

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: LoperamideExperimental Treatment1 Intervention
Patients will receive 4 mg loperamide per os 15 minutes prior injection of the 4FMFES radiotracer dose. As a peristalsis inhibitor, it is expected that this medication will slow down the intestinal progression of the radio-metabolite bolus and thus spare the lower abdomen (where the assessed organs of interest are) of overwhelming background that could impair diagnosis.
Group II: Hyoscine-N-butylbromideExperimental Treatment1 Intervention
In a similar fashion that what is used for some gastro-intestinal radiological examinations, repeated intravenous injection of 20 mg hyoscine-N-butylbromide will be applied at 0, 20 and 40 minutes following 4FMFES injection. As a peristalsis inhibitor, it is expected that this medication will slow down the intestinal progression of the radio-metabolite bolus and thus spare the lower abdomen (where the assessed organs of interest are) of overwhelming background that could impair diagnosis.
Group III: Control groupActive Control1 Intervention
4FMFES injection is performed as usual, no supplemental medication is used.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hyoscine-n-butylbromide
2018
N/A
~100

Find a Location

Who is running the clinical trial?

Université de SherbrookeOTHER
289 Previous Clinical Trials
68,861 Total Patients Enrolled
Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
57 Previous Clinical Trials
31,081 Total Patients Enrolled
Éric Turcotte, MDPrincipal InvestigatorUniversité de Sherbrooke

Frequently Asked Questions

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

What ailments is hyoscine-n-butylbromide commonly prescribed for?

"Hyoscine-n-butylbromide can ameliorate ailments ranging from acute biliary spasm, chronic functional diarrhea to muscle tissue related issues."

Answered by AI

Are there vacancies for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour has been actively seeking participants since it was posted on September 1st 2018 and last revised October 31st 2022. 72 individuals are needed from a single centre for the trial's completion."

Answered by AI

To what extent has participation in this experiment been embraced?

"Indeed, the information hosted on clinicaltrials.gov affirms that this trial is actively recruiting participants since its inception in September 2018 and most recent update in October 2022. 72 volunteers are needed to complete the study conducted at a single site."

Answered by AI

Can you provide a summary of the prior studies done with hyoscine-n-butylbromide?

"Currently, 10 research projects exploring hyoscine-n-butylbromide are underway with one in the advanced Phase 3 trials. Initially centered around Nagoya-shi, Aichi, this medication's clinical trial locations have now expanded to 157 sites worldwide."

Answered by AI

Is this experiment the inaugural exploration of its kind?

"Currently, 10 active trials dedicated to hyoscine-n-butylbromide are present in 63 cities and 20 countries. This medication was first studied by Eli Lilly and Company back in 2014 with 198 participants and has since completed its Phase 1 drug approval stage. Subsequently, a total of 52 studies have been conducted on the subject matter."

Answered by AI
~11 spots leftby Mar 2025