FFNP PET/MRI for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jorge Oldan, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must be taking: Levonorgestrel IUD

Disqualifiers: Claustrophobia, Metallic implants, Pregnancy, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a hormonal device and a special scan to see if they can predict how well women with certain uterine conditions will respond to treatment. The device releases a hormone to stop abnormal cell growth, and the scan checks if it's working.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have had prior hormonal treatment for CAH or Grade 1 EC.

What data supports the effectiveness of the drug 18F-fluorofuranylnorprogesterone PET/MRI for endometrial cancer?

Research shows that similar compounds, like 21-fluoro-16 alpha-methyl-19-norprogesterone, have high specificity for progesterone receptors, which are often present in endometrial cancer. This suggests that 18F-fluorofuranylnorprogesterone could effectively target and image these receptors, helping in the assessment and management of the disease. ^{1 2 3 4 5}

How is FFNP PET/MRI different from other treatments for endometrial cancer?

FFNP PET/MRI is unique because it combines a special imaging agent, 18F-fluorofuranylnorprogesterone, with advanced MRI techniques to provide detailed images of endometrial cancer. This approach may offer better insights into the cancer's characteristics and help tailor treatment plans more effectively compared to traditional imaging methods. ^{5 6 7 8 9}

Research Team

Jorge Oldan, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for women aged 18 or older with confirmed Complex Atypical Hyperplasia (CAH) or Grade 1 Endometrial Cancer (EC), who are planning to be treated with a Levonorgestrel-releasing Intrauterine Device (LR-IUD). Participants should not have had previous surgical or hormonal treatments for these conditions. Women with certain metal implants, allergies to gadolinium or FFNP, severe kidney issues, pregnancy, prior hormone treatment for breast cancer, or extreme claustrophobia cannot join.

Inclusion Criteria

I am planning to use an IUD for my uterine condition.

My condition is confirmed as CAH or Grade 1 endometrial cancer.

I have not had surgery or hormone treatment for CAH or early-stage endometrial cancer.

Exclusion Criteria

Inability to complete PET/MR scans due to severe claustrophobia

Implanted metallic devices, parts, vascular clips, or other foreign bodies

I am not pregnant, confirmed by a recent test or my medical history.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants receive one FFNP PET/MRI scan to establish baseline measurements

1 day

1 visit (in-person)

Treatment

Participants undergo treatment with Levonorgestrel-releasing Intrauterine Device (LR-IUD) and are monitored for response

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 18F-fluorofuranylnorprogesterone PET / MRI (Corticosteroid)

Trial Overview The study is testing the effectiveness of an imaging scan called FFNP PET/MRI in predicting how well CAH and EC respond to hormonal therapy via LR-IUD. It's a small-scale pilot study involving eight participants who will undergo one FFNP PET/MRI scan each and have their medical records reviewed over six months.

Participant Groups

Group I: 18F-fluorofuranylnorprogesterone PET / MRI Experimental Treatment 1 Intervention

All enrolled subjects will receive the tracer and then have a PET/MRI scan.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Dr. Shelley Earp

UNC Lineberger Comprehensive Cancer Center

Chief Medical Officer since 2018

MD from Johns Hopkins Medical School

Dr. Robert L. Ferris

UNC Lineberger Comprehensive Cancer Center

Chief Executive Officer

PhD in Immunology and MD from Johns Hopkins Medical School; Bachelor's in Chemistry from UNC-Chapel Hill

Radiological Society of North America

Collaborator

Trials

27

Recruited

1,000+

Findings from Research

The study identified 21-fluoro-16 alpha-methyl-19-norprogesterone ([18F]FMNP) as a promising imaging agent for detecting progesterone receptor positive tumors, showing high specificity and minimal binding to other steroid receptors.

In vivo tests in rats demonstrated that [18F]FMNP had significantly higher uptake in uterine and tumor tissues compared to blood, correlating strongly with progesterone receptor concentrations, indicating its potential for effective imaging of progesterone receptor positive neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of a positron emitting progestin ([18F]fluoro-16 alpha-methyl-19-norprogesterone) for imaging progesterone receptor positive tumours with positron emission tomography. Verhagen, A., Luurtsema, G., Pesser, JW., et al.[2019]

In a study of 62 endometrial cancer patients, higher levels of 18F-FDG uptake (measured as SUVmax) were associated with negative estrogen receptor (ER) and progestogen receptor (PR) expression, indicating that lower SUVmax values may suggest a better response to progestogen therapy.

The study found that 18F-FDG PET/CT can accurately predict ER and PR status with an accuracy of 74.2%, which could help guide treatment decisions for patients with endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between the expression of oestrogen receptor and progesterone receptor and 18F-FDG uptake in endometrial cancer. Wu, C., Chen, R., Xu, L., et al.[2021]

Non-contrast 18F-FDG PET/MRI demonstrated a high diagnostic accuracy for assessing the primary tumor in endometrial cancer, with an accuracy of 77.8%, comparable to contrast-enhanced MRI (75.0%).

For detecting regional nodal metastasis, 18F-FDG PET/MRI showed superior sensitivity (100%) compared to contrast-enhanced CT (14.3%), indicating its potential as a more effective diagnostic tool in preoperative staging of endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of 18F-FDG PET/MRI for staging in patients with endometrial cancer. Tsuyoshi, H., Tsujikawa, T., Yamada, S., et al.[2020]

Endometrial cancer, the second most common gynecological cancer, is often diagnosed early due to symptoms like post-menopausal bleeding, which increases the chances of successful treatment.

Magnetic resonance imaging (MRI) plays a crucial role in determining the stage of endometrial cancer, aiding in the decision-making process for treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR staging of endometrial carcinoma. Messiou, C., Spencer, JA., Swift, SE.[2006]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of a positron emitting progestin ([18F]fluoro-16 alpha-methyl-19-norprogesterone) for imaging progesterone receptor positive tumours with positron emission tomography. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Relationship between the expression of oestrogen receptor and progesterone receptor and 18F-FDG uptake in endometrial cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of progesterone receptors in breast carcinoma by PET with 21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Accuracy of MRI with an endorectal coil for staging endometrial cancer. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Diagnostic value of 18F-FDG PET/MRI for staging in patients with endometrial cancer. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Diagnostic performance of fluorine 18 fluorodeoxyglucose positron emission tomography imaging for detection of primary lesion and staging of endometrial cancer patients: systematic review and meta-analysis of the literature. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Staging of endometrial carcinomas with MRI using traditional and novel MRI techniques. [2022]

8. England pubmed.ncbi.nlm.nih.gov

MR staging of endometrial carcinoma. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

The Emerging Role of PET/MR Imaging in Gynecologic Cancers. [2017]