Clinical trial · Interventional
PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas
Utility of PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Treatment of High Grade Sarcomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/MR | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm: PET/MR
- description
- 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).
- interventionNames
- Diagnostic Test: PET/MR
Primary outcomes (1)
- measure
- PET Activity Estimates at Midpoint of Treatment as Compared to Baseline
- timeFrame
- At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
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