Clinical Trials Logo
  1. Home
  2. Metastatic Malignant Neoplasm
  3. NCT05174026
  4. Details
NCT05174026 Clinical Trial

18F-FDG PET-MRI for Planning and Follow-Up of Patients With Spine Tumors Treated With Spine Stereotactic Radiosurgery

Metastatic Malignant Neoplasm Clinical Trial

Official title:
A Pilot Study on the Efficacy of Advanced 18F-FDG PET-MRI in Spine Stereotactic Radiosurgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05174026
Other study ID # 2017-0788
Secondary ID NCI-2019-0826120
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 30, 2018
Est. completion date December 31, 2023

Study information
Verified date December 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies how well 18F-FDG PET-MRI works for treatment planning in patients with spine tumors. Diagnostic procedures, such as 18F-FDG PET-MRI may help radiation oncologists plan the best treatment for spine tumors, as well as help in follow-up after radiation therapy.

Description:

PRIMARY OBJECTIVES: I. Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI) in spine stereotactic radiosurgery (SSRS) treatment planning compared to advanced MRI (aMRI) and conventional MRI (cMRI). II. Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients treated with SSRS. SECONDARY OBJECTIVES: I. Analysis of the subset of patients who eventually suffer local treatment failure to determine patterns of failure and potential predictive PET/MRI features at baseline. II. Analysis of the subset of patients who suffer complications of SSRS (e.g., vertebral compression fracture) to determine potential predictive imaging features. OUTLINE: Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute, and then undergo PET-MRI over 1 hour, 30 days before radiation therapy, and 3 and 6 months after radiation therapy.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Consent to imaging study - Presence of at least 1 lumbar vertebral body bone metastasis > 1 cm in shortest diameter and smaller than 75% of the vertebral body cross sectional area. Metastasis may be determined by pathology, or imaging appearance. - Eligibility to receive SSRS (determined by treating radiation oncologists) - Plan for single-fraction SSRS - Standard-of-care spine MRI within 8 weeks of radiation therapy - Ability to understand and willingness to sign a written informed consent document - Non-English speaking participants will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking participants. Exclusion Criteria: - Absolute or relative contra-indication to MRI, including presence of a pacemaker that requires involvement of cardiology/anesthesiology during the scan - Prior directed radiation to the involved segment - Contra-indication to gadolinium based contrast agents (e.g., allergy, pregnancy) - Individuals younger than 18 years - Hardware at the treatment level or hardware affecting visualization of the involved level on MRI - Pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Fludeoxyglucose F-18
Given IV
Procedure:
• Magnetic Resonance Imaging
Undergo 18F-FDG PET-MRI
• Positron Emission Tomography
Undergo 18F-FDG PET-MRI

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI). up to 6 months
Primary Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients. up to 6 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03796767 - Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer Phase 2
Completed NCT00936975 - Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases Phase 2
Recruiting NCT02699697 - Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis N/A
Withdrawn NCT05010096 - BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04693377 - Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial N/A
Recruiting NCT03858205 - Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma N/A
Active, not recruiting NCT03793166 - Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study Phase 3
Not yet recruiting NCT05924672 - Efficacy of Ra-223 in PSMA PET Optimally Selected Patients Phase 2
Terminated NCT03649841 - Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer Phase 2
Terminated NCT04928820 - 68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy Phase 2
Completed NCT01833208 - Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T N/A
Recruiting NCT04071223 - Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, the RadiCaL Study Phase 2
Active, not recruiting NCT04754425 - Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer Phase 2
Completed NCT03204812 - Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Completed NCT02499835 - Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer Phase 1/Phase 2
Completed NCT03749460 - Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers Phase 1/Phase 2
Completed NCT03691493 - Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis Phase 2
Active, not recruiting NCT02099864 - Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy Phase 2
Terminated NCT02565901 - Sirolimus, Docetaxel, and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer Phase 1/Phase 2
Completed NCT03012230 - Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer Phase 1

External Links