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NCT02415816 · ClinicalTrials.gov registry record · NA
Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas
A NA study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- NA
- Development phase
- 98
- Enrollment target
NCT02415816: Completed NA study, sponsored by St. Jude Children's Research Hospital.
NCT02415816 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 98 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02415816, a NA study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
Study Summary
Children with sarcomas are routinely assessed with a variety of imaging techniques that involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone scan, and positron emission tomography-CT (PET-CT). Pediatric sarcoma patients undergo many imaging studies at the time of diagnosis, during therapy and for years following completion of therapy. Because children are in a stage of rapid growth, their tissues and organs are more susceptible to the harmful effects of ionizing radiation than are adults. Furthermore, compared to adults, children have a longer life expectancy and, therefore, a longer period of time in which to develop the adverse sequelae of radiation exposure, such as the development of second malignancies. Alternative experimental methods of measuring tumor response will be compared to current standard of care measures to determine if the experimental method is equivalent to methods currently being used. Investigators wish to determine if they can reduce patient's exposure to the harmful effects of ionizing radiation by replacing imaging studies that use radiation with whole body diffusion weighted magnetic resonance imaging (DW-MRI) which does not use any radiation. They also want to know if DW-MRI measurements of the tumor can tell how well the tumor is responding to therapy. There have been studies in adults with cancer that have shown that DW-MRI provides useful information about how tumors are responding to therapy. There have only been very small studies of DW-MRI in children with tumors in the body. Therefore, the role of DW-MRI in pediatric sarcoma patients is not yet known and it is still experimental. This study might give us important information that could help us treat other children with bone or soft tissue sarcomas in the future.
Primary Outcome
To allow for blinding, reading of scan images will be delayed at least 2 months and up to 6 months following scan. Proportion of participants whose bone/bone marrow and soft-tissue metastases were detected with whole body DWI MRI
Interventions
- PROCEDURE Diffusion Weighted Magnetic Resonance Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2015-06-05 |
| Est. Completion | 2022-10-28 |
| Phase | NA |
What the finished NCT02415816 record still lists
NCT02415816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Diffusion Weighted Magnetic Resonance Imaging is the first listed.
NCT02415816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02415816 about?
NCT02415816 is a clinical study titled "Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas". Children with sarcomas are routinely assessed with a variety of imaging techniques that involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone scan, and positron emission tomography-CT (PET-CT). Pediatric sarcoma patients undergo many imaging studies at the time ...
What is the current status of trial NCT02415816?
This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2015-06-05. Estimated completion is 2022-10-28.
What interventions are being tested in trial NCT02415816?
The interventions under investigation include: Diffusion Weighted Magnetic Resonance Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT02415816?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02415816's enrollment target sits among peer trials
98 922nd of 2000 higher than 1,078 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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