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PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas

Primary Purpose

Sarcoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/MR
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC-Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm: PET/MR

Arm 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).

Outcomes

Primary Outcome Measures

PET Activity Estimates at Midpoint of Treatment as Compared to Baseline
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.

Secondary Outcome Measures

PET Activity Estimates at Endpoint of Treatment as Compared to Baseline
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.

Full Information

First Posted
March 6, 2017
Last Updated
March 2, 2021
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03076333
Brief Title
PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas
Official Title
Utility of PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Treatment of High Grade Sarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Investigators propose that a PET/MR study at the midpoint of radiation treatment will accurately predict which patients will respond to neoadjuvant radiation therapy. The study will enroll patients with high-grade sarcomas as identified by preoperative biopsy that will be treated with neoadjuvant radiation into the study. The standard of care for these patients is to receive MRI scans at pre-treatment and post-treatment time points. Patients in this study will receive their standard pre- and post-treatment imaging in the form of PET/MR, with PET conducted simultaneously with MRI, and within the context of the study they will also receive one additional PET/MR at the end of the second week of therapy. These patients will then receive curative intent surgery and be followed in the usual fashion and assessed for local and/or distant recurrent disease. The pathology will be assessed for completeness of resection and percent of necrosis. On the basis of pathology, patients will be classified as responsive or non-responsive to therapy. Quantitative measures from PET and MRI will be computed: the change in PET tumor-mean standardized uptake value (SUV) and tumor size as assessed by MRI, from pre- to post-treatment, and from pre- to mid-treatment. The image-based quantitative measures will be correlated with the pathology outcomes to evaluate predictability of the image measures for treatment response. Patients will be followed with the intent of further correlating image measures with clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm: PET/MR
Arm Type
Experimental
Arm 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).
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MR
Intervention Description
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.
Primary Outcome Measure Information:
Title
PET Activity Estimates at Midpoint of Treatment as Compared to Baseline
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.
Time Frame
At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.
Secondary Outcome Measure Information:
Title
PET Activity Estimates at Endpoint of Treatment as Compared to Baseline
Description
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.
Time Frame
A post-treatment PET/MR is obtained at 4 weeks post radiation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Lalush, PhD
Organizational Affiliation
UNC Biomedical Engineering
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://unclineberger.org
Description
UNC Lineberger Comprehensive Cancer Center

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PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas

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