18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Purpose: The purpose of this study is to evaluate FFNP PET/MRI's utility for predicting response to Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC).

Participants: Eight women with histologically confirmed CAH or Grade 1 EC who have planned treatment with LR-IUD will be recruited..

Procedures (methods): The is a prospective, single arm, pilot study of 8 participants who will receive one FFNP PET/MRI scan. Medical records will be followed for 6 months.

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

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: Radiological Society of North America

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