PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas

NCT03076333 | Completed Results DMC FDA Device

• 1 other identifier: LCCC 1615
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To assess the utility of PET/MR in assessing response to neoadjuvant radiation therapy in the treatment of high grade sarcomas. Participants: Adult patients with potentially curable high grade sarcomas that are being treated at UNC with neoadjuvant radiation therapy followed by potentially curative surgical resection. Procedures (methods): Patients who are being treated for potentially curable high grade sarcomas with neoadjuvant radiation therapy followed by surgical resection undergo pre-treatment, mid-treatment, and post-treatment PET/MR and the response to treatment is assessed by evaluating change in size and FDG avidity. Patients then undergo curative intent resection and are followed. Their pathology is reviewed for treatment affect as is assessed by percent necrosis, size, and resection margins. Patients are followed and assessed for recurrence.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• PET Activity Estimates at Midpoint of Treatment as Compared to Baseline

  Primary endpoint is the determination of differences among response groups in PET activity estimates from PET/MR imaging at the midpoint of treatment as compared to baseline. The measure is computed as the change in mean SUV from the baseline PET-MR scan to the scan at the end of the second week of therapy. Treatment response will be determined on final pathological evaluation of the resected specimens in patients who undergo curative intent surgery after neoadjuvant radiation in high grade sarcomas. This will be measured by a single sarcoma specialized pathologist and will be categorized as to the percentage of necrosis, with \>90% necrosis considered to be complete response.

  At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.

Secondary Outcomes (1)

• PET Activity Estimates at Endpoint of Treatment as Compared to Baseline

  A post-treatment PET/MR is obtained at 4 weeks post radiation.

Study Arms (1)

Single Arm: PET/MR

EXPERIMENTAL

Each patient will undergo three combined PET/MR scans. The pre-treatment PET, mid-treatment PET and MR, and post-treatment PET are for research purposes and not part of the patient's standard of care (pre-treatment MR and post-treatment MR).

Diagnostic Test: PET/MR

Interventions

PET/MR DIAGNOSTIC_TEST

Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist. At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR. The patient will the complete their radiation therapy. Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates.

Single Arm: 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 a biopsy-proven high-grade retroperitoneal or soft tissue extremity sarcoma confirmed by independent evaluation of a UNC sarcoma specialized pathologist.
• Must have surgically curable disease as evaluated by initial imaging by our UNC surgeons.
• Must be in acceptable health to undergo radiation therapy and curative intent surgery as assessed by UNC surgeons and radiation oncologist.
• Must be able to understand and comply with study procedures for the entire length of the study.
• Must receive their neoadjuvant radiation therapy and curative intent surgery at UNC Hospitals - Chapel Hill location.
• Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to each 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
• Poorly controlled diabetes mellitus
• Creatinine \> 1.8 mg/dL OR GFR \< 30mL/min
• Body Mass Index (BMI) \> 35
• Active vaginal bleeding requiring packing and emergent radiation therapy
• Pregnancy or lactating female
• History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years
• 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 radiation therapy or curative intent surgery
• Previous radiation exposure precluding radiation therapy
• Had serious reaction to contrast agent
• 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

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Limitations and Caveats

Small numbers of subjects limit data interpretation.

Results Point of Contact

• Title: David S Lalush
• Organization: Joint UNC/NC State Department of Biomedical Engineering

dslalush@ncsu.edu

919-513-7671

Study Officials

• David Lalush, PhD

  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: March 6, 2017
• First Posted: March 10, 2017
• Study Start: April 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: January 31, 2020
• Last Updated: March 26, 2021
• Results First Posted: March 26, 2021

Record last verified: 2021-01

Locations

US (1)