Soft TissueNCT03458520
Pediatric PET/MR Image Registry
An observational study of Soft Tissue and Lymphoma, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Read more about this study
- Who is it for?
- Ages Up to 40 years
- Conditions the study is for
- Soft Tissue, Lymphoma, Osteosarcoma
- What is being tested?
- PET/MR imaging, MR imaging and PET/CT imaging
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Dec 2026
- Phase
- Observational
- 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 Up to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric and young adult (<40 years) male or female subjects with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor
Who may be able to join
- Patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor.
- We might also include some patients with leukemia if there is concern for a focal lesion in any of their organs.
- Participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry.
Who cannot join
- Patient has contraindications for MRI or PET/MR. This includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level > 200 mg/dl.
- Lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age).
- Patient has a CNS primary tumor.
- Pregnant women and fetuses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University, School of Medicine
Palo Alto, California, 94304
Anne Muehe, 650-720-8601, amuehe@stanford.edu
Heike Daldrup-Link, MD
About this study
The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.
- Conditions
- Soft Tissue, Lymphoma, Osteosarcoma
- Being tested
- PET/MR imaging, MR imaging, PET/CT imaging
- Medical subject headings
- Lymphoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR imagingDiagnostic test
Also called positron emission tomography
undergo PET/MR imaging
MR imagingDiagnostic test
Also called magnetic resonance imaging
Undergo MR imaging
PET/CT imagingDiagnostic test
Also called computed tomography
Undergo PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Image Registry | patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor will receive MR imaging, PET/MR imaging (and if available, PET/CT imaging) Receives: Diagnostic Test: PET/MR imaging; Diagnostic Test: MR imaging; Diagnostic Test: PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tumors
Number of tumors detected on whole body MRI, PET/MR and (if available) PET/CT scans.
Measured: up to 12 months
Secondary outcomes (1)
Metabolic activity of tumors
Metabolic activity of tumors determined by Standardized Uptake Values (SUV) on PET/MR and (if available) PET/CT scans.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Feb 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft TissueStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heike Daldrup-Link, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458520
- Sponsor's protocol ID
- IRB-44706
- Other IDs
- PEDSVAR0049, 5U24CA264298-04
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2018
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric PET/MR Image Registry
- ClinicalTrials.gov ID
- NCT03458520
- Acronym / sponsor ID
- IRB-44706
- Conditions
- Soft Tissue, Lymphoma, Osteosarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Mar 2018 (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.
The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Image Registry | – | Diagnostic Test: PET/MR imaging, Diagnostic Test: MR imaging, Diagnostic Test: PET/CT imagingpatients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor will receive MR imaging, PET/MR imaging (and if available, PET/CT imaging) |
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric and young adult (<40 years) male or female subjects with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor
Key inclusion criteria (3 listed)
- Patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor.
- We might also include some patients with leukemia if there is concern for a focal lesion in any of their organs.
- Participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry.
Key exclusion criteria (4 listed)
- Patient has contraindications for MRI or PET/MR. This includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level > 200 mg/dl.
- Lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age).
- Patient has a CNS primary tumor.
- Pregnant women and fetuses
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 |
|---|---|---|
| PET/MR imagingAlso: positron emission tomographyundergo PET/MR imaging | Diagnostic test | Image Registry |
| MR imagingAlso: magnetic resonance imagingUndergo MR imaging | Diagnostic test | Image Registry |
| PET/CT imagingAlso: computed tomographyUndergo PET/CT imaging | Diagnostic test | Image Registry |
Primary outcome
Number of tumors
Time frame: up to 12 months
Number of tumors detected on whole body MRI, PET/MR and (if available) PET/CT scans.
1 secondary outcome
Metabolic activity of tumors
Time frame: up to 12 months
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 9 Feb 2026.
Related trials for Soft Tissue
Active, not recruitingPhase 1
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
Leiomyosarcoma, Soft-tissue Sarcomas
Active, not recruitingPhase 3
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study
Clear Cell Renal Cell Carcinoma, Metastatic Malignant Neoplasm in the Bone
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
Recruiting
Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infections
Recruiting
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
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.
Heike Daldrup-Link, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue and Lymphoma, run by Stanford University at 1 site in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Feb 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 United States. 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.
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?
Contact Anne Muehe (650-720-8601, amuehe@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tumors (time frame: up to 12 months). 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 9 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.