An Imaging Drug (FFNP) PET/MRI for the Detection of Response to Progesterone Therapy in Patients with Complex Atypical Hyperplasia and Grade I Endometrial Cancer

Status: withdrawn

This clinical trial tests how well administration of fluorine F18 fluoro furanyl norprogesterone (FFNP) contrast agent in combination with positron emission tomography (PET)/magnetic resonance imaging (MRI) works in predicting response to treatment with planned levonorgestrel-releasing intrauterine device (LR-IUD) hormonal therapy in patients with complex atypical hyperplasia (CAH) or grade I endometrial cancer (EC). LR-IUD is a form of long term progesterone therapy for treatment of CAH/EC patients when removal of the uterus (hysterectomy) is not an option in these patients. FFNP is a radioactive contrast agent that helps show abnormal areas inside the body by imaging (radiotracer) by binding to progesterone receptors. Progesterone receptor is a protein found inside the cells of the female reproductive tissue, some other types of tissue, and some cancer cells. Using FFNP with PET/MRI scans may help doctors predict the response to hormonal therapy.

Inclusion Criteria

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
Pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine beta human chorionic gonadotropin (beta-HCG) results, obtained within 24 hours before FFNP administration, or on the basis of patient history, as defined by the University of North Carolina [UNC] institutional review board [IRB] standard operating procedures [SOP] 4801.)
Prior hormone treatment for breast cancer

PRIMARY OBJECTIVES:

I. To evaluate the sensitivity of fluorine F 18 fluoro furanyl norprogesterone (18F-fluorofuranylnorprogesterone [FFNP]) FFNP PET/MR for predicting response to progestin therapy in complex atypical hyperplasia (CAH)/endometrial carcinoma (EC) patients.

II. To evaluate the specificity of 18F-fluorofuranylnorprogesterone (FFNP) FFNP PET/MR for predicting response to progestin therapy in CAH/EC patients.

SECONDARY OBJECTIVES:

I. To correlate FFNP uptake (standardized uptake value mean [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.

II. To correlate FFNP uptake (standardized uptake value maximum [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.

OUTLINE:

Patients receive fluorine F 18 fluoro furanyl norprogesterone intravenously (IV) and undergo a PET/MRI scan on study.

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An Imaging Drug (FFNP) PET/MRI for the Detection of Response to Progesterone Therapy in Patients with Complex Atypical Hyperplasia and Grade I Endometrial Cancer

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