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

Solid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02376127
• Other study ID #: 14-203
• Status: Active, not recruiting
• Start date: February 24, 2015
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Metastatic Spinal Lesions
• Solid Cancer

Intervention

Procedure:
• Dynamic contrast enhancement MRI

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to treatment	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center