Using FFNP PET/MRI to predict response to hormonal therapy in endometrial conditions
18-fluorofuranylnorprogesterone (FFNP) Positron Emission Tomography-Magnetic Resonance Imaging (PET/MRI) as a Potential Biomarker of Response to Progesterone Therapy in Complex Atypical Hyperplasia (CAH) and Grade 1 Endometrial Cancer (EC)
This study is trying to see if a special type of scan can help predict how well women with certain endometrial conditions will respond to a hormonal treatment using an intrauterine device.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05483023 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a biomarker for predicting how well patients with Complex Atypical Hyperplasia (CAH) or Grade 1 Endometrial Cancer (EC) will respond to treatment with a levonorgestrel-releasing intrauterine device (LR-IUD). It is a prospective, single-arm pilot study involving eight women who have been diagnosed with these conditions and are scheduled to receive the LR-IUD. Participants will undergo one FFNP PET/MRI scan, and their medical records will be monitored for six months to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 or older with histologically confirmed CAH or Grade 1 EC who have not undergone prior surgical or hormonal treatments.
Not a fit: Patients with severe claustrophobia, certain medical conditions, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to predict treatment responses, potentially improving patient outcomes in CAH and EC.
How similar studies have performed: While this approach is novel, similar imaging techniques have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female age 18 or older * Histologically confirmed CAH or Grade 1 EC * No prior surgical or hormonal treatment for CAH or Grade 1 EC * Planned treatment with levonorgestrel-releasing intrauterine device (LR-IUD) for CAH or grade 1 EC Exclusion Criteria: * Inability to complete PET/MR scans due to severe claustrophobia * Institutionalized subject (prisoner or nursing home subject) * Implanted metallic devices, parts, vascular clips, or other foreign bodies. * Known hypersensitivity to gadolinium or FFNP or to any component of gadolinium or FFNP refractory to standard medications (antihistamines, steroids) * Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis. * Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine (β-HCG) results, obtained within 24 hours before FFNP administration, or on the basis of patient history) * Prior hormone treatment for breast cancer
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jorge Oldan, MD — University of North Carolina, Chapel Hill
- Study coordinator: Markeela Lipscomb, CCRC
- Email: markeela_lipscomb@med.unc.edu
- Phone: 919-843-3670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.