RhabdomyosarcomaPhase 1NCT03054792
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
A Phase 1 study testing Blood Oxygen Level Dependent [BOLD] MRI, Diffusion-Weighted [DW] MRI and Magnetic Resonance Spectroscopy [MRS] in people with Rhabdomyosarcoma and Non-Rhabdo. Soft Tissue Sarcoma, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Rhabdomyosarcoma, Non-Rhabdo. Soft Tissue Sarcoma
- What is being tested?
- Blood Oxygen Level Dependent [BOLD] MRI, Diffusion-Weighted [DW] MRI and Magnetic Resonance Spectroscopy [MRS]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
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.
- Conditions
- Rhabdomyosarcoma, Non-Rhabdo. Soft Tissue Sarcoma
- Being tested
- Blood Oxygen Level Dependent [BOLD] MRI, Diffusion-Weighted [DW] MRI, Magnetic Resonance Spectroscopy [MRS]
- Medical subject headings
- Rhabdomyosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Oxygen Level Dependent [BOLD] MRIDiagnostic 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] MRIDiagnostic 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]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
| Study group | Role | What they receive |
|---|---|---|
| BOLD- DW- MRS | Experimental | Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS] Receives: Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI; Diagnostic Test: Diffusion-Weighted [DW] MRI; Diagnostic Test: Magnetic Resonance Spectroscopy [MRS] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with response to therapy
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.
Measured: 1 year
Secondary outcomes (1)
Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 May 2017
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyosarcomaStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Doria, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054792
- Sponsor's protocol ID
- 1000049533
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2017
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
- ClinicalTrials.gov ID
- NCT03054792
- Acronym / sponsor ID
- 1000049533
- Conditions
- Rhabdomyosarcoma, Non-Rhabdo. Soft Tissue Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOLD- DW- MRS | Experimental | Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI, Diagnostic Test: Diffusion-Weighted [DW] MRI, Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS] |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Oxygen Level Dependent [BOLD] MRIBOLD 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. | Diagnostic test | BOLD- DW- MRS |
| Diffusion-Weighted [DW] MRIDW 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 | Diagnostic test | BOLD- DW- MRS |
| 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 | Diagnostic test | BOLD- DW- MRS |
Primary outcome
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.
1 secondary outcome
Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. No IPD data will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blood Oxygen Level Dependent [BOLD] MRI, Diffusion-Weighted [DW] MRI and Magnetic Resonance Spectroscopy [MRS] in people with Rhabdomyosarcoma and Non-Rhabdo. Soft Tissue Sarcoma, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with response to therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.