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NCT04823065CompletedPhase 1/2

4FMFES-PET Imaging of Endometrial and Ovarian Cancers

4FMFES Positron Emission Tomography (PET) for Detection of Newly-diagnosed ER+ Endometrial and Ovarian Cancers

Source: ClinicalTrials.gov · Last updated 13 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
53 (actual)
First submitted
24 Mar 2021
Start date
1 Sept 2018
Primary completion date
31 Aug 2023
Lead sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
NCT number
NCT04823065

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 53
  • From 1 Sept 2018 to the primary completion date, 31 Aug 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • Cirrhosis, acute or chronic hepatitis, or any other hepatic problem that might impede the normal elimination of the PET tracer, or;

Other

  • Pregnancy, or;
  • Hypersentivity to either FDG or 4FMFES, or any of their consittuants.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre de recherche du CHUS
Coordinator of this site? Confirm its status
SherbrookeCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.