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Metastatic Spinal Bone Marrow Response to Radiation Therapy Using T1 Weighted Dynamic Contrast-Enhanced Perfusion

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ClinicalTrials.gov Identifier: NCT02376127
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the spine. The study aims to see if using these methods will help better see response to treatment with radiation in patients with spine metastases from any solid cancer.

Condition or disease Intervention/treatment
Solid Cancer Metastatic Spinal Lesions Procedure: Dynamic contrast enhancement MRI

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Metastatic Spinal Bone Marrow Response to Radiation Therapy Using T1 Weighted Dynamic Contrast-Enhanced Perfusion
Actual Study Start Date : February 24, 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Group/Cohort Intervention/treatment
pts with known spinal metastases
(20 patients from any solid cancer) who are to undergo radiation treatment (RT) will be recruited. The patients will undergo DCE-MRI before and after RT. RT will be classified as success based on evidence of tumor contraction on conventional MRIs, negative PET, or stability for more than 11 months and blinded from DCE MRI sequencing. For each patient, a scanning profile for the first scan will be saved and used for the follow-up scans to acquire the same locations over time. Each patient will be scanned 4 times (one pre-treatment and 3 follow up post treatment) during their consecutive clinical visits. The DCE MRI sequence is a part of MR sequences for standard care. No additional scans will be added in the standard clinical sequences.
Procedure: Dynamic contrast enhancement MRI



Primary Outcome Measures :
  1. response to treatment [ Time Frame: 2 years ]
    will be based on clinical assessment and conventional MRI and PET imaging, evaluating images for evidence of tumor contraction and stable disease for more than 11 months. Clinical assessment is done by radiation oncology and is based on physical examination, patient symptoms and consideration of radiological studies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Criteria

Inclusion Criteria:

  • Adult patients 18 years of age or older
  • Known pathological diagnosis of any solid cancer.
  • Metastatic spinal lesions 1 cm or greater in diameter.
  • Patients who are already eligible for and are to be treated with hypofractionated or single dose radiation for their spinal lesions.

Note: The patients must have their treatments at MSKCC.

Exclusion Criteria:

  • Patients with renal failure or history of allergic reaction to Gadavist will be excluded.
  • Patients who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Disease Screening Questionnaire for MRI.
  • Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
  • Patients with inability to cooperate for an MRI exam due to claustrophobia or high levels of anxiety.
  • Female patients who are pregnant or nursing.
  • Patients with eGFR < 30 are not eligible to higher risk of NSF.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376127


Contacts
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Contact: Sasan Karimi, MD 212-639-8633
Contact: Kyung Peck, PhD 212-639-8522

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Sasan Karimi, MD    212-639-8633      
Contact: Kyung Peck, PhD    212-639-8522      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Bayer
Investigators
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Principal Investigator: Sasan Karimi, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02376127    
Other Study ID Numbers: 14-203
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Dynamic Contrast-Enhanced Perfusion
14-203
Additional relevant MeSH terms:
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