Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT03076333
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03076333
Study Brief:
Protocol Section:
NCT03076333