PET/MR Characterization of Renal Cell Carcinomas

NCT04271254 | Terminated Results DMC FDA Device

• 1 other identifier: LCCC 1930
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 (ccRCC) to potentially inform prognosis and treatment decisions. Participants: Seventeen subjects diagnosed with clear-cell renal cell carcinoma (ccRCC) will be imaged in a single session on PET-MRI. Procedures (methods): The investigators will image 17 ccRCC subjects on simultaneous PET-MRI and quantify the metabolically-active fraction of the tumor from images. Ten core samples will be taken from each tumor post-surgery and classified as ccA or ccB subtype using transcriptome analysis. The imaging-based measures will be correlated with the fraction of tumor cores classified as ccB.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Correlation Between PET Activity Distribution and Tumor Subtype Composition

  The correlation between Positron Emission Tomography (PET) activity distribution and tumor subtype composition will be assessed as the relation of PET activity estimates (in the form of fractional tumor volume over PET SUV threshold of 2.0) and the fraction of tumor cores classified as ccB subtype by transcriptome analysis. Ten core samples will be taken from each tumor at surgery time and will be examined with a panel of 34 genes found to distinguish ccA and ccB subtypes. The single subject's tissue analysis will not done immediately following surgery because the study was planned from the beginning to bank the tissue samples and analyze them all at once at the completion of the study.

  PET/MR scans will be taken within four weeks prior to surgery. Tissue samples will be taken at the time of surgery. (from the PET/MR scan to Surgery Day=Day 1)

Study Arms (1)

PET/MR

EXPERIMENTAL

Each patient will undergo one combined PET/MR scan prior to surgery. The PET/MR scans are for research purposes and not part of the patient's standard of care.

Diagnostic Test: PET/MR

Interventions

PET/MR DIAGNOSTIC_TEST

Patient will be scheduled for a pre-surgery PET/MR within four weeks of scheduled surgery.

PET/MR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC- Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: David Lalush
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

dlalush@email.unc.edu

9195137671

Study Officials

• David Lalush

  UNC Biomedical Engineering

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: October 1, 2020
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: August 24, 2023
• Results First Posted: August 24, 2023

Record last verified: 2023-08

Locations

US (1)