Trial Outcomes & Findings for PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas (NCT NCT03076333)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.

Results posted on

2021-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	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). 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.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm: PET/MR n=3 Participants 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). 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.
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=3 Participants
Age, Categorical >=65 years	2 Participants n=3 Participants
Age, Continuous	69 years n=3 Participants
Sex: Female, Male Female	1 Participants n=3 Participants
Sex: Female, Male Male	2 Participants n=3 Participants
Region of Enrollment United States	3 participants n=3 Participants
Pre-treatment tumor SUV mean	3.78 SUV n=3 Participants

PRIMARY outcome

Timeframe: At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.

Population: All participants

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.

Outcome measures

Outcome measures
Measure	Single Arm: PET/MR n=3 Participants 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). 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	.44 SUV Interval -0.3 to 2.72

SECONDARY outcome

Timeframe: A post-treatment PET/MR is obtained at 4 weeks post radiation.

Population: All participants

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. The measure is computed as the change in mean SUV from the baseline PET-MR scan to the scan taken four weeks after completion of therapy.

Outcome measures

Outcome measures
Measure	Single Arm: PET/MR n=3 Participants 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). 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 Endpoint of Treatment as Compared to Baseline	-.51 SUV Interval -1.04 to -0.03

Adverse Events

Single Arm: PET/MR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David S Lalush

Joint UNC/NC State Department of Biomedical Engineering

Phone: 919-513-7671

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place