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

UNC Lineberger Comprehensive Cancer Center

Status and phase: Withdrawn; Phase 2

Conditions: Endometrial Cancer; Complex Atypical Hyperplasia

Treatments: Drug: 18F-fluorofuranylnorprogesterone PET / MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05483023

LCCC2221

22-1677 (Other Identifier)

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

18F-fluorofuranylnorprogesterone PET / MRI

Experimental group

Description:

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

Treatment:

Drug: 18F-fluorofuranylnorprogesterone PET / MRI