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Radiation

18F-FDG PET-MRI for Spine Cancer

N/A

Waitlist Available

Led By Behrang Amini

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial is testing how well an MRI that can show how much sugar is being used by cells works for treatment planning in patients with spine tumors.

Who is the study for?

This trial is for patients with spine tumors who consent to imaging studies, have a lumbar vertebral body bone metastasis larger than 1 cm but smaller than 75% of the vertebra's area. They must be eligible for and planning on single-fraction SSRS treatment, with a standard MRI done within the last 8 weeks. Excluded are those with MRI contraindications like pacemakers needing special care during scans, prior radiation at the same spot, or issues with gadolinium contrast agents.Check my eligibility

What is being tested?

The study is examining how effective an advanced imaging technique called 18F-FDG PET-MRI is in planning and monitoring treatment for patients undergoing Spine Stereotactic Radiosurgery (SSRS) for spine tumors. It aims to improve precision in targeting tumors and assessing post-treatment outcomes.See study design

What are the potential side effects?

While not directly related to side effects from medication, this trial involves exposure to radiation from PET-MRI scans which may carry a risk of discomfort or allergic reactions due to contrast agents used during the procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients.

Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI).

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293

19%

87900-Vomiting(targeted toxicity)

15%

11400-Agitation

11600-Alanine aminotransferase increased

16800-Bladder infection

44800-Infections and infestations - Other specify

58700-Nystagmus

15000-Aspartate aminotransferase increased

88500-White blood cell decreased

15300-Ataxia

33900-Fever

25700-Diarrhea

43100-Hypokalemia

69700-Rash maculo-papular(targeted toxicity)

13200-Anemia

33300-Febrile neutropenia

57600-Nausea(targeted toxicity)

20500-Catheter related infection

58300-Neutrophil count decreased

41300-Hypercalcemia

41400-Hyperglycemia(targeted toxicity)

41600-Hyperkalemia

42600-Hypoalbuminemia

42700-Hypocalcemia

64400-Personality change

41500-Hyperhidrosis

13500-Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Chemotherapy, Immunoglobulin Therapy)

Arm II (Chemotherapy, Observation)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (18F-FDG PET-MRI)Experimental Treatment3 Interventions

Patients receive fludeoxyglucose F-18 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,771 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,143 Total Patients Enrolled

Behrang AminiPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participants in this experiment?

"Unfortunately, this investigation is not currently searching for participants. The trial was first published on November 30th 2018 and most recently modified on August 11th 2022. Despite these parameters, there are still 2495 other clinical trials actively welcoming new members."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "18F-FDG PET-MRI for Planning and Follow-Up of Patients With Spine Tumors Treated With Spine Stereotactic Radiosurgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05174026.