PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas
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|ClinicalTrials.gov Identifier: NCT03076333|
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : November 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Diagnostic Test: PET/MR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utility of PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Treatment of High Grade Sarcomas|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Single Arm: PET/MR
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).
Diagnostic Test: PET/MR
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.
- PET activity estimates at midpoint of treatment as compared to baseline [ Time Frame: At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained. ]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. 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.
- PET activity estimates at endpoint of treatment as compared to baseline [ Time Frame: A post-treatment PET/MR is obtained at 4 weeks post radiation. ]A secondary endpoint is the determination of differences among response groups in PET activity estimates from PET/MR imaging at the endpoint of treatment as compared to baseline. Secondary endpoints also include the determination of differences among response groups in MRI tumor size fractional change from baseline-to-mid-treatment and from baseline-to-post-treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076333
|Contact: Soma Prum, MSemail@example.com|
|Contact: Kristine Baluyot, BSfirstname.lastname@example.org|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Kristine Baluyot|
|Principal Investigator:||David Lalush, PhD||UNC Biomedical Engineering|