4FMFES-PET Imaging of Endometrial and Ovarian Cancers

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Collaborator: Université de Sherbrooke
• Treatments: Antidiarrheals; Butylscopolammonium Bromide; Loperamide; Scopolamine

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.