18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy
NCT ID: NCT05483023
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2024-02-15
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-fluorofuranylnorprogesterone PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan.
18F-fluorofuranylnorprogesterone PET / MRI
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Interventions
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18F-fluorofuranylnorprogesterone PET / MRI
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Radiological Society of North America
OTHER
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jorge Oldan, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Other Identifiers
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22-1677
Identifier Type: OTHER
Identifier Source: secondary_id
LCCC2221
Identifier Type: -
Identifier Source: org_study_id
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