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Trial Title:
18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy
NCT ID:
NCT05483023
Condition:
Complex Atypical Hyperplasia
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Hyperplasia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-fluorofuranylnorprogesterone PET / MRI
Description:
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Arm group label:
18F-fluorofuranylnorprogesterone PET / MRI
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.
Criteria for eligibility:
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
Gender:
Female
Gender based:
Yes
Gender description:
Participant eligibility is based on the biological gender assigned at birth.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Markeela Lipscomb, CCRC
Phone:
919-843-3670
Email:
markeela_lipscomb@med.unc.edu
Contact backup:
Last name:
Louis Murphy
Phone:
919-966-2544
Email:
louis_murphy@med.unc.edu
Investigator:
Last name:
Jorge Oldan, MD
Email:
Principal Investigator
Investigator:
Last name:
Victoria Bae-Jump, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yueh Lee, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Kristen Olinger, MD
Email:
Sub-Investigator
Start date:
February 15, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Radiological Society of North America
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483023
