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

NCT ID: NCT02376127

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-24

Study Completion Date

2025-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Cancer Metastatic Spinal Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Dynamic contrast enhancement MRI

Intervention Type PROCEDURE

Interventions

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Dynamic contrast enhancement MRI

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sasan Karimi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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14-203

Identifier Type: -

Identifier Source: org_study_id

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