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:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT01561495
Eligibility Criteria:
Inclusion Criteria:
* Patients with a histologic diagnosis of soft tissue sarcoma of the extremities are eligible for this study.
* Patient must be 18 years of age.
* Patients must have evidence of disease limited to the extremities.
* For the pre-operative group, patients must be considered operable/resectable and a candidate for pre-operative radiotherapy as judged by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. All patients in the pre-operative group will be evaluated for this protocol PRIOR to the initiation of therapy.
* For the post-operative group, patients must be considered operable/resectable (if evaluated prior to resection) and a candidate for post-operative radiotherapy by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. Patients in the post-operative group may be evaluated PRIOR to the initiation of any therapy or may be referred for evaluation after surgical resection.
* ECOG status of 0-2.
* Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable to sign informed consent are excluded from the study.
* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.
* Negative urine pregnancy test for females of childbearing potential on the day of the F18-EF5 PET scan prior to F18-EF5 injection
Exclusion Criteria:
* Pregnant women, women planning to become pregnant and women that are nursing.
* Patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01561495
Study Brief:
Protocol Section:
NCT01561495