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

Active, not recruiting

• Conditions: Solid Cancer; Metastatic Spinal Lesions
• Interventions: Procedure: Dynamic contrast enhancement MRI

• Registration Number: NCT02376127
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-24
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pts with known spinal metastases	Dynamic contrast enhancement MRI	(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.

Primary Outcome Measures

Name	Time	Method
response to treatment	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States