Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
Trial Snapshot
- Phase
- Phase 1
- Status
- Enrolling By Invitation
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of participants with response to therapy
Study Overview
Brief Summary
This study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI and Magnetic Resonance Spectroscopy (MRS) with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma [RMS] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component;
- •Candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy
Exclusion Criteria
- •Patients with general contraindications for an MRI scan (metal foreign body, pacemaker, inability to tolerate an examination without sedation);
- •Patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy;
- •Patients with no clinical indication for neoadjuvant therapy prior to surgery;
- •Patients with chronic pulmonary disease;
- •Patients with other diagnosis confirmed after initial suspicion of RMS or non-RMS.
Arms & Interventions
BOLD- DW- MRS
Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS]
Intervention: Blood Oxygen Level Dependent [BOLD] MRI (Diagnostic Test)
BOLD- DW- MRS
Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS]
Intervention: Diffusion-Weighted [DW] MRI (Diagnostic Test)
BOLD- DW- MRS
Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS]
Intervention: Magnetic Resonance Spectroscopy [MRS] (Diagnostic Test)
Outcomes
Primary Outcomes
Number of participants with response to therapy
Time Frame: 1 year
Response will be assessed by measurements of tumor volume, percentage of BOLD signal changes, percentage of tumor necrosis, apparent diffusion coefficient, concentration of high-energy and low-energy phosphates in tumor.
Secondary Outcomes
- Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.(1 year)
Investigators
Andrea Doria
Radiologist, Scientist, Research Director
The Hospital for Sick Children