4FMFES-PET Imaging of Endometrial and Ovarian Cancers

NCT04823065 | Completed Phase 1

• 1 other identifier: CIMS-2019-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer; Ovarian Cancer

Keywords

PET; 4FMFES; Endometrial cancer; Ovarian cancer

Outcome Measures

Primary Outcomes (3)

• Evaluate 4FMFES-PET diagnostic properties in endometrial and ovarian cancers

  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).

  48 months

• Compare 4FMFES-PET with standard FDG-PET in gynaecological cancers.

  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.

  48 months

• Use pharmaceutical intervention to slow down peristalsis to improve lower-abdomen 4FMFES-PET

  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.

  48 months

Study Arms (3)

Control group

NO INTERVENTION

4FMFES injection is performed as usual, no supplemental medication is used.

Loperamide

EXPERIMENTAL

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

Hyoscine-N-butylbromide

EXPERIMENTAL

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

Interventions

Loperamide Pill DRUG

4 mg Imodium, per os

Also known as: Imodium

Loperamide

hyoscine-n-butylbromide DRUG

3 X 20 mg Buscopan, intravenous

Also known as: Buscopan

Hyoscine-N-butylbromide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Université de Sherbrooke: collaborator

Study Sites (1)

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Paquette M, Espinosa-Bentancourt E, Lavallee E, Phoenix S, Lapointe-Milot K, Bessette P, Guerin B, Turcotte EE. 18F-4FMFES and 18F-FDG PET/CT in Estrogen Receptor-Positive Endometrial Carcinomas: Preliminary Report. J Nucl Med. 2022 May;63(5):702-707. doi: 10.2967/jnumed.121.262617. Epub 2021 Aug 19.

  PMID: 34413142 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Ovarian Neoplasms

Interventions

Loperamide; Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Éric Turcotte, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical research, CRCHUS

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 30, 2021
• Study Start: September 1, 2018
• Primary Completion: August 31, 2023
• Study Completion: April 30, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CA (1)