PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional

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.
    

Intervention name(s): PET/MR
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic