- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00598741
Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients with histologically proven diagnoses of OS or Ewing Sarcoma undergoing induction chemotherapy are eligible for study.
- Patients/guardians must provide written consent. It is anticipated that many of these patients will be minors and consent will be obtained from their parent/guardian.
- The presence of the evaluable primary tumor is required.
Exclusion Criteria:
- Inability to cooperate for an MRI.
- Absence of evaluable primary tumor
- Known reaction to Gd-DTPA
- Pre-operative radiation to primary tumor site
Contraindication to MRI
- Pacemaker
- Aneurysmal clips
- Metal implants in field of view
- Any other conditions that result in patients not being appropriate for MRI. study
- Pregnancy
- Age and mental status wherein he/she is able to cooperate for MRI study
- Unusual histopathologic subvariants (radiation induced, Paget's disease, hereditary RB)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Patients will undergo DCE-MRI prior to, and within 18-24 days of starting chemotherapy. These studies are designed to determine if the DCE-MRI data will provide an a priori or early prognostic marker of tumor response. The dynamic MRI is done on a standard clinical scanner using standard techniques described below. MR imaging studies will be acquired on a 1.5T GE (Milwaukee,WI) Signa LX scanner. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pts will undergo baseline MRI prior to begin chemotherapy. Bet 18-24 days after beginning chemotherapy, they will undergo second MRI. They will continue chemotherapy and w/in 25 days prior definitive surgery, will undergo another MRI.
Time Frame: 8 years
|
8 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jason Koutcher, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-083
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
-
Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
Brown UniversityActuate Therapeutics Inc.WithdrawnSoft Tissue Sarcoma | Osteosarcoma | Ewing Sarcoma of Bone | Leiomyosarcoma | High Grade Sarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Bone Sarcoma | Synovial Sarcoma | Undifferentiated Pleomorphic Sarcoma | Myxofibrosarcoma | Spindle Cell SarcomaUnited States
-
Centre Oscar LambretFrench Sarcoma Group; Study Group of Bone TumorsCompletedSoft Tissue Sarcoma | Uterine SarcomaFrance
-
University of WashingtonAadi Bioscience, Inc.Active, not recruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedBone Cancer | Chondrosarcoma | Recurrent Osteosarcoma | Clear Cell Sarcoma of the Kidney | Metastatic Osteosarcoma | Ovarian Sarcoma | Recurrent Adult Soft Tissue Sarcoma | Recurrent Uterine Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage III Uterine Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage...United States
Clinical Trials on DCE-MRI
-
Stanford UniversityColumbia University; University of ManchesterRecruiting
-
Yonsei UniversityUnknownAdvanced Adult Hepatocellular CarcinomaKorea, Republic of
-
University of UtahCompleted
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupUnknownBreast Cancer | BIRADS 3 | BIRADS 4 | BIRADS 5United States
-
OHSU Knight Cancer InstituteRadiological Society of North America; Medical Research Foundation, OregonTerminatedHead and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institute of Dental and Craniofacial...Recruiting
-
Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)Active, not recruitingHead and Neck CancerUnited States
-
Memorial Sloan Kettering Cancer CenterCompletedOvarian CancerUnited States
-
Loma Linda UniversityCompletedCerebrovascular Disorders | Brain InjuriesUnited States
-
Memorial Sloan Kettering Cancer CenterOregon Health and Science University; DeltaPoint,Inc.Completed