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hyoscine-n-butylbromide for Ovarian Cancer

Phase 1 & 2
Waitlist Available
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
Be older than 18 years old
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

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
Completed Phase 2
~150
Loperamide Pill
2018
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Université de SherbrookeOTHER
298 Previous Clinical Trials
69,888 Total Patients Enrolled
Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
60 Previous Clinical Trials
31,148 Total Patients Enrolled
Éric Turcotte, MDPrincipal InvestigatorUniversité de Sherbrooke
~8 spots leftby Jun 2025
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