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4FMFES-PET Imaging of Endometrial and Ovarian Cancers

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ClinicalTrials.gov Identifier: NCT04823065
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
Université de Sherbrooke
Information provided by (Responsible Party):
Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Brief Summary:

This project is about exploring a novel method to detect ovarian and uterine cancers earlier and better. More precisely, a high-performance radioactive estrogen analog will be used to visualize hormone-sensitive uterine and ovarian tumors using PET imaging. Not only this imaging methodology could improve the whole-body assessment of those diseases, but will also hint clinicians about the optimal course of therapy to undertake.

The lead investigator's team designed in the past years an innovative radioactive estrogen derivative tracer (4FMFES) for the medical imaging modality termed Positron Emission Tomography (PET). The compound was first shown to be safe for human use. Recently, a clinical trial demonstrated that 4FMFES-PET is superior to any existing comparable tracer for detection of hormone-sensitive breast cancer patients. 4FMFES is particularly useful to pinpoint unsuspected metastases early, which allowed better breast cancer patient management and staging. 4FMFES and standard FDG PET imaging were shown to be complementary in breast cancer, the use of both techniques together providing a detection rate nearing 100%. Since ovarian and uterine cancers are about as likely to be targeted by 4FMFES as breast cancer, the use of this novel precision imaging method will be adapted to those other indications.

In general, the sooner a cancer is diagnosed and treated, the better the outcome of a patient will be. Gynecological cancers lack precise screening and detection tools. In particular, while a majority of uterine cancers are relatively well managed, patients burdened with metastatic burden have a much worse prognosis, and precise and early detection of those lesions will greatly help clinicians to better treat those complicated cases. As for ovarian cancers, they are usually devoid of clinical symptoms until late onset, which partly explain the high mortality rate of this disease. Hence, for both diseases, a precision, whole-body imaging technique will allow earlier assessment, followed by earlier intervention, resulting in improved survival rate and better quality of life for patients.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Ovarian Cancer Drug: Loperamide Pill Drug: hyoscine-n-butylbromide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

All recruited patients will undergo a 4FMFES-PET after biopsy confirmation of a ER+ endometrial cancer or suspicion of ovarian cancer. All patients are scanned prior to surgery.

Patients are then randomly distributed for 3 different interventions aiming to reduce the intestinal peristalsis in order to diminish abdominal background generated by 4FMFES radio-metabolites.

  1. Control group: no intervention other than standard 4FMFES injection;
  2. 4 mg loperamide, per os, 15 minutes prior to 4FMFES injection;
  3. Repeated i.v. injection of 20 mg hyoscine-N-butylbromide at 0, 20 and 40 minutes after 4FMFES injection.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 4FMFES Positron Emission Tomography (PET) for Detection of Newly-diagnosed ER+ Endometrial and Ovarian Cancers
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022


Arm Intervention/treatment
No Intervention: Control group
4FMFES injection is performed as usual, no supplemental medication is used.
Experimental: Loperamide
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.
Drug: Loperamide Pill
4 mg Imodium, per os
Other Name: Imodium

Experimental: Hyoscine-N-butylbromide
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.
Drug: hyoscine-n-butylbromide
3 X 20 mg Buscopan, intravenous
Other Name: Buscopan




Primary Outcome Measures :
  1. Evaluate 4FMFES-PET diagnostic properties in endometrial and ovarian cancers [ Time Frame: 48 months ]
    4FMFES-PET ability to detect tumors and assess extend of the disease will be monitored with both qualitative and semi-quantitative parameters. The 4FMFES uptake of each assessed lesion will be reported as Standard Uptake Value (SUV).

  2. Compare 4FMFES-PET with standard FDG-PET in gynaecological cancers. [ Time Frame: 48 months ]
    When available, 4FMFES-PET sessions will be scheduled within 2 weeks of a standard FDG-PET examination. The Standard Uptake Value (SUV)-derived tumor uptake will be compared between each tracer. The radiological, surgical and pathological assessment will be used as standard confirmation of the presence and size of tumors to confirm PET's finding.

  3. Use pharmaceutical intervention to slow down peristalsis to improve lower-abdomen 4FMFES-PET [ Time Frame: 48 months ]
    Patients that undergoes 4FMFES-PET will be assigned to 1) no-intervention control group; 2) 4 mg loperamide per os; 3) repeated 20 mg hyoscine-N-butylbromide injection. The volume occupied by excreted radio-metabolites (via the hepatobiliary pathway) will be estimated by applying a SUV < 4.0 threshold on a region-of-interest covering the whole abdomen.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who received a biopsy-confirmed diagnosis of a ER+ endometrial cancer, or;
  • Women with a suspected ovarian cancer, or;
  • Women with recurrent endometrial or ovarian cancer and with a ER+ primary tumor, and;
  • Planned surgery, and;
  • Stage 1A cancer and more, with primary more than 1 cm, and;
  • Able to tolerate supine position, and;
  • Written consent given by the patient.

Exclusion Criteria:

  • Pregnancy, or;
  • Replacement hormone therapy concomitant to 4FMFES-PET, or;
  • Use of estrogen-based oral contraceptives concomitant to 4FMFES-PET, or;
  • Anti-tumor hormone therapy that compete with estrogen receptors concomitant to 4FMFES-PET, such as tamoxifen and fulvestrant. Withdrawal of such therapies 8 weeks prior to the 4FMFES-PET scan will enable the patient to the imaging test, or;
  • Cirrhosis, acute or chronic hepatitis, or any other hepatic problem that might impede the normal elimination of the PET tracer, or;
  • Hypersentivity to either FDG or 4FMFES, or any of their consittuants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823065


Contacts
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Contact: Michel Paquette, PhD 819-346-1110 ext 11982 michel.paquette@usherbrooke.ca
Contact: Stéphanie Dubreuil 819-346-1110 ext 16617 stephanie.dubreuil2@usherbrooke.ca

Locations
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Canada, Quebec
Centre de recherche du CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Michel Paquette, PhD    819-346-1110 ext 11982    michel.paquette@usherbrooke.ca   
Contact: Stéphanie Dubreuil    819-346-1110 ext 16617    stephanie.dubreuil2@usherbrooke.ca   
Principal Investigator: Éric Turcotte, MD         
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Université de Sherbrooke
Investigators
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Principal Investigator: Éric Turcotte, MD Université de Sherbrooke
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Responsible Party: Dr Éric E Turcotte, MD, Head of clinical research, CRCHUS, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT04823065    
Other Study ID Numbers: CIMS-2019-01
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke:
PET
4FMFES
Endometrial cancer
Ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Uterine Diseases
Scopolamine
Loperamide
Antidiarrheals
Butylscopolammonium Bromide
Gastrointestinal Agents
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Mydriatics
Cholinergic Antagonists
Cholinergic Agents