Status:
TERMINATED
PET/MR Characterization of Renal Cell Carcinomas
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Purpose: To evaluate the utility of simultaneous positron emission tomography (PET) and magnetic resonance imaging (MRI) in characterizing the molecular subtypes of clear cell renal cell carcinomas (c...
Detailed Description
Simultaneous PET/MR imaging \[1\]-\[7\] offers exciting opportunities to visualize and quantify soft-tissue tumors \[2\]. MRI offers superb soft-tissue contrast for anatomical information as well as a...
Eligibility Criteria
Inclusion
- Age ? 18 years of age (no upper age limit)
- Signed, IRB-approved written informed consent
- Must have clinically-suspected ccRCC based on prior imaging with tumor size \>= 7 cm.
- Planned nephrectomy schedule that can accommodate a MR-FDG-PET scan within 4 weeks prior to surgery.
- Must be able to meet size restrictions for the PET-MR scanner.
- Must be able to understand and comply with study procedures for the entire length of the study.
- Must receive their nephrectomy at UNC Hospitals.
- If patient has a history of prior malignancy, including melanoma, patient must be cancer-free for three or more years. Non-melanoma skin cancers will be included even if not cancer-free for three years.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to PET/MRI.
Exclusion
- Inability to tolerate MRI (e.g., inability to lie flat for \>1 hour)
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Failure of two blood glucose tests (blood glucose level greater than 200 mg/dL) on day of first scheduled scan visit and on rescheduled day.
- Body Mass Index (BMI) \> 35
- Patient receiving neoadjuvant therapy for RCC
- Pregnancy or lactating female
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
- Evidence of distant disease on physical exam or initial imaging
- Medical conditions precluding chemotherapy or curative intent surgery
- Incarcerated or otherwise institutionalized at time of enrollment
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04271254
Start Date
October 1 2020
End Date
June 14 2023
Last Update
August 24 2023
Active Locations (1)
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1
UNC- Chapel Hill
Chapel Hill, North Carolina, United States, 27599