CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3 enrolled
Drug / intervention
PET/MRother
Likely dose
Not stated in record
Key inclusion· 5
  • Age ≥18 years with no upper age limit
  • Biopsy-proven high-grade retroperitoneal or soft tissue extremity sarcoma confirmed by independent pathology review
  • Surgically curable disease as assessed by initial imaging
  • Acceptable health to undergo radiation therapy and curative intent surgery
Key exclusion· 12
  • Inability to tolerate MRI or lie flat for >1 hour
  • Pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant, or metal near eyes or pelvis causing excessive imaging artifact
  • Poorly controlled diabetes mellitus
  • Creatinine >1.8 mg/dL or GFR <30 mL/min

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03076333
NCT03076333N/ACompleted

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

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Mar 10, 2017·Updated Mar 26, 2021

In Brief

A clinical study evaluating PET/MR for Sarcoma. Completed, enrolled 3 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 10, 2017
Enrollment StartApr 1, 2018
Primary CompletionDec 30, 2019
Study CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.3 years ago

Interventions

PET/MRother

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.