Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/10/2019 |
| Start Date: | June 5, 2015 |
| End Date: | April 2027 |
| Contact: | Mary E. McCarville, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
Diffusion Weighted Magnetic Resonance Imaging in Pediatric 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 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.
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.
Whole body (WB) and primary tumor diffusion weighted imaging (DWI) will be performed at
baseline in all subjects. Additional DW-MRIs will be done up to 3 times during treatment at
the same time as routine MRI examinations are scheduled. Follow-up primary tumor DWI MRI
examinations will be performed at time points determined by the participant's therapeutic
treatment protocol. Follow-up primary tumor DWI examinations will be performed until
completion of local control (surgical resection or completion of radiation therapy). All
examinations will be performed on 1.5T Siemens magnetic resonance (MR) scanners unless there
is a clinical indication for 3T imaging.
Because investigators will correlate imaging parameters with patient outcome, participants
will be followed until they are discharged to the After Completion of Therapy Clinic or until
they have tumor progression or recurrence or develop a second malignancy or death, whichever
comes first.
PRIMARY OBJECTIVES:
- To estimate the proportion of pediatric sarcoma patients whose bone/bone marrow and
soft-tissue metastasis status are correctly staged by whole body diffusion weighted MRI
(WB DWI) at the time of diagnosis by comparing it to clinical stage.
- To determine the correlation between changes in primary pediatric sarcoma
18F-fluorodeoxyglucose positron emission tomography (FDG PET) maximum standardized
uptake values (SUVmax) and average DWI apparent diffusion coefficient (ADC) values from
baseline (pre-treatment) to just prior to local control.
OTHER PRESPECIFIED OBJECTIVES:
- To estimate the sensitivity, specificity, accuracy, and negative and positive predictive
values of WB DWI, PET-CT and PET-CT + bone scan for detecting sites of metastatic tumor
in pediatric sarcomas using biopsy or clinical follow-up (including imaging studies and
clinical information) as the reference standards.
- To compare the ability of WB MRI, PET-CT and PET-CT + bone scan to detect all sites of
metastases in pediatric sarcoma patients using biopsy and clinical judgment as the
reference standards.
- To examine the associations of DWI ADC values of primary tumors at diagnosis and
treatment protocol driven time points during therapy with tumor histology, tumor grade,
RECIST response, % tumor necrosis, FDG SUVmax and patient outcome.
- To compare whole body DWI to conventional T1W and STIR whole body MRI for the detection
of nodal, bone/bone marrow, soft-tissue or lung metastases among pediatric bone and
soft-tissue sarcoma patients using biopsy and clinical judgment as the reference
standards.
- To investigate the value of a variety of quantitative parameters obtained from software
analysis of the primary tumor, such as; histogram kurtosis, range, peak, shifts in peak,
or tumor heterogeneity.
baseline in all subjects. Additional DW-MRIs will be done up to 3 times during treatment at
the same time as routine MRI examinations are scheduled. Follow-up primary tumor DWI MRI
examinations will be performed at time points determined by the participant's therapeutic
treatment protocol. Follow-up primary tumor DWI examinations will be performed until
completion of local control (surgical resection or completion of radiation therapy). All
examinations will be performed on 1.5T Siemens magnetic resonance (MR) scanners unless there
is a clinical indication for 3T imaging.
Because investigators will correlate imaging parameters with patient outcome, participants
will be followed until they are discharged to the After Completion of Therapy Clinic or until
they have tumor progression or recurrence or develop a second malignancy or death, whichever
comes first.
PRIMARY OBJECTIVES:
- To estimate the proportion of pediatric sarcoma patients whose bone/bone marrow and
soft-tissue metastasis status are correctly staged by whole body diffusion weighted MRI
(WB DWI) at the time of diagnosis by comparing it to clinical stage.
- To determine the correlation between changes in primary pediatric sarcoma
18F-fluorodeoxyglucose positron emission tomography (FDG PET) maximum standardized
uptake values (SUVmax) and average DWI apparent diffusion coefficient (ADC) values from
baseline (pre-treatment) to just prior to local control.
OTHER PRESPECIFIED OBJECTIVES:
- To estimate the sensitivity, specificity, accuracy, and negative and positive predictive
values of WB DWI, PET-CT and PET-CT + bone scan for detecting sites of metastatic tumor
in pediatric sarcomas using biopsy or clinical follow-up (including imaging studies and
clinical information) as the reference standards.
- To compare the ability of WB MRI, PET-CT and PET-CT + bone scan to detect all sites of
metastases in pediatric sarcoma patients using biopsy and clinical judgment as the
reference standards.
- To examine the associations of DWI ADC values of primary tumors at diagnosis and
treatment protocol driven time points during therapy with tumor histology, tumor grade,
RECIST response, % tumor necrosis, FDG SUVmax and patient outcome.
- To compare whole body DWI to conventional T1W and STIR whole body MRI for the detection
of nodal, bone/bone marrow, soft-tissue or lung metastases among pediatric bone and
soft-tissue sarcoma patients using biopsy and clinical judgment as the reference
standards.
- To investigate the value of a variety of quantitative parameters obtained from software
analysis of the primary tumor, such as; histogram kurtosis, range, peak, shifts in peak,
or tumor heterogeneity.
Inclusion Criteria:
- All St Jude patients with a known or suspected, newly diagnosed bone or soft-tissue
sarcoma who will be treated on or as per disease specific protocols.
- Study subjects will have undergone or are scheduled for PET-CT and/or bone scan within
about 2 weeks of the WB and primary tumor DWI MRI.
- No limit on age or gender
- Informed consent or assent signed by study subject or parent/guardian according to
institutional guidelines.
- Patients should not have begun therapy, or, needed research imaging can be performed
within 2-5 days of starting therapy.
Exclusion Criteria:
- Subject has a tumor that will undergo upfront resection
- Subject is unable or unwilling to follow study requirements, including signed consent
or assent
- Subject is hospitalized in the intensive care unit.
- Subject does not meet institutional MRI safety screening requirements.
- Subject has undergone primary tumor resection prior to arrival at St. Jude.
- Subjects who require sedation for WB MRI will be excluded if they have:
- An acute cardiopulmonary process including, but not limited to, croup, reactive
airways disease, pneumonia, clinical or radiological evidence of pericardial
effusion or other cardiopulmonary disease.
- Vomiting within 24 hours of the MRI or substantial nausea that may preclude
sedation as determined by the anesthesiologist or certified registered nurse
anesthetist.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Mary E. McCarville, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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