Complex Atypical HyperplasiaPhase 2NCT05483023
18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy
A Phase 2 study testing 18F-fluorofuranylnorprogesterone PET / MRI in people with Complex Atypical Hyperplasia and Endometrial Cancer, run by UNC Lineberger Comprehensive Cancer Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Complex Atypical Hyperplasia, Endometrial Cancer
- What is being tested?
- 18F-fluorofuranylnorprogesterone PET / MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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)
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.
- Conditions
- Complex Atypical Hyperplasia, Endometrial Cancer
- Being tested
- 18F-fluorofuranylnorprogesterone PET / MRI
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluorofuranylnorprogesterone PET / MRIDrug
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRI | Experimental | All enrolled subjects will receive the tracer and then have a PET/MRI scan. Receives: Drug: 18F-fluorofuranylnorprogesterone PET / MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect areas that will respond to treatment, as determined by histopathologic evaluation.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
The specificity is similarly defined as the ability of readers to determine areas that will fail to respond to treatment, as determined by histopathologic evaluation.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary outcomes (2)
Correlate FFNP Mean Standardized Uptake Value (SUVmean) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.
The association between SUVmean and tumor volume and the degree of estrogen/progesterone receptor will be evaluated using random coefficient trajectory models, separately for each outcome. These models allow a separate outcome trajectory for each patient, accounting for within-patient correlations arising from the fact that measurements are taken at multiple timepoints. Estrogen/progesterone receptor will be included as a fixed effect, along with the interaction of this fixed effect and time. A p-value <0.05 for this interaction will be considered evidence that the association between the outcome and estrogen/progesterone receptor varies by time. A patient-level random intercept will be included in the models. Differences in predicted means of the outcomes at each time point will be computed and tested to see if they differ from 0; p-values <0.05 for these tests will be considered evidence of a difference in predicted means by estrogen/progesterone values.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Correlate FFNP Maximum Standardized Uptake Value (SUVmax) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.
The association between SUVmax and tumor volume and the degree of estrogen/progesterone receptor will be evaluated using random coefficient trajectory models, separately for each outcome. These models allow a separate outcome trajectory for each patient, accounting for within-patient correlations arising from the fact that measurements are taken at multiple timepoints. Estrogen/progesterone receptor will be included as a fixed effect, along with the interaction of this fixed effect and time. A p-value <0.05 for this interaction will be considered evidence that the association between the outcome and estrogen/progesterone receptor varies by time. A patient-level random intercept will be included in the models. Differences in predicted means of the outcomes at each time point will be computed and tested to see if they differ from 0; p-values <0.05 for these tests will be considered evidence of a difference in predicted means by estrogen/progesterone values.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start15 Feb 2024
- Primary completion28 Jun 2026 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Drug cannot be produced and scanner down.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Atypical HyperplasiaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Sponsor
- Investigators
- Jorge Oldan, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483023
- Sponsor's protocol ID
- LCCC2221
- Other IDs
- 22-1677
- Status last verified
- Oct 2025
- First submitted
- 28 Jul 2022
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05483023
- Acronym / sponsor ID
- LCCC2221
- Conditions
- Complex Atypical Hyperplasia, Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug cannot be produced and scanner down.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRI | Experimental | Drug: 18F-fluorofuranylnorprogesterone PET / MRIAll enrolled subjects will receive the tracer and then have a PET/MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRISubjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer | Drug | 18F-fluorofuranylnorprogesterone PET / MRI |
Primary outcome
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect areas that will respond to treatment, as determined by histopathologic evaluation.
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
The specificity is similarly defined as the ability of readers to determine areas that will fail to respond to treatment, as determined by histopathologic evaluation.
2 secondary outcomes
Correlate FFNP Mean Standardized Uptake Value (SUVmean) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
Correlate FFNP Maximum Standardized Uptake Value (SUVmax) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Related trials for Complex Atypical Hyperplasia
RecruitingObservational study
The DETECT Study: Discovery and Evaluation of Testing for Endometrial and Ovarian Cancer in Tampons
Endometrial Cancer, Endometrial Cancer Precursors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Oldan, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-fluorofuranylnorprogesterone PET / MRI in people with Complex Atypical Hyperplasia and Endometrial Cancer, run by UNC Lineberger Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients (time frame: Upon completion of all study image data collection for all participants [approximately 1 year]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.