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Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

NCT ID: NCT03054792

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rhabdomyosarcoma Non-Rhabdo. Soft Tissue Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BOLD- DW- MRS

Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI, MR Spectroscopy \[MRS\]

Group Type EXPERIMENTAL

Blood Oxygen Level Dependent [BOLD] MRI

Intervention Type DIAGNOSTIC_TEST

BOLD is a non-invasive T2\*-weighted MRI technique that is sensitive to the microvascular deoxyhemoglobin concentration. BOLD has the potential to monitor changes in tissue oxygenation in response to a gas breathing challenge to induce contrast.

Diffusion-Weighted [DW] MRI

Intervention Type DIAGNOSTIC_TEST

DW MRI is a non-invasive technique that provides quantitative biophysical information about the movement of water in tissues and reflects the anisotropy of normal and pathologic cells

Magnetic Resonance Spectroscopy [MRS]

Intervention Type DIAGNOSTIC_TEST

MRS is a non-invasive imaging technique that enables the generation of spectral profiles of low molecular weight metabolites that reflect status of a tissue

Interventions

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Blood Oxygen Level Dependent [BOLD] MRI

BOLD is a non-invasive T2\*-weighted MRI technique that is sensitive to the microvascular deoxyhemoglobin concentration. BOLD has the potential to monitor changes in tissue oxygenation in response to a gas breathing challenge to induce contrast.

Intervention Type DIAGNOSTIC_TEST

Diffusion-Weighted [DW] MRI

DW MRI is a non-invasive technique that provides quantitative biophysical information about the movement of water in tissues and reflects the anisotropy of normal and pathologic cells

Intervention Type DIAGNOSTIC_TEST

Magnetic Resonance Spectroscopy [MRS]

MRS is a non-invasive imaging technique that enables the generation of spectral profiles of low molecular weight metabolites that reflect status of a tissue

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Andrea Doria

Radiologist, Scientist, Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000049533

Identifier Type: -

Identifier Source: org_study_id