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

Completed · Not applicable

Conditions studied: Sarcoma

In brief

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.

Key facts

Study ID

NCT03076333

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

3

Starts

2018-04-01

Expected to finish

2020-01-31

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UNC-Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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