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Contrast Agent

FDG PET-MRI for Spinal Cord Conditions

N/A
Waitlist Available
Led By Maria K Gule-Monroe
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
Patients with untreated intramedullary cord lesion(s)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 hours
Awards & highlights

Study Summary

This trial is testing when is the best time to use F18-FDG to get the best image on PET-MRI for patients with spinal cord lesions of unknown cause.

Who is the study for?
This trial is for adults with untreated spinal cord lesions who can have an FDG PET MR scan. It's not for those who've had previous surgery or biopsy of the spinal cord, have metal implants in the area, past spine radiation therapy, are pregnant, under 18 years old, need sedation to tolerate the study, have high blood sugar levels (>200 mg/dl), or allergies to FDG or gadolinium contrast.Check my eligibility
What is being tested?
The trial tests how well Fludeoxyglucose F-18 (FDG) combined with PET-MRI works in diagnosing spinal cord tumors. Participants will receive FDG and then undergo PET-MRI scans at different times to see which provides better information.See study design
What are the potential side effects?
Possible side effects include reactions to the FDG contrast like nausea or a rash. MRI and PET scans are generally safe but may cause discomfort due to lying still for long periods and loud noises during scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have untreated spinal cord lesions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lesion to background (L/B) ratio
Optimal imaging time point
Standard uptake value (SUV) max

Side effects data

From 2011 Phase 2 trial • 55 Patients • NCT00062374
65%
Fatigue
64%
Hypocalcemia
60%
Nausea
58%
White blood cell count decrease
56%
Neutrophil count decrease
55%
Hemoglobin decrease
45%
Diarrhea
38%
Platelet count decreased
36%
Hyponatremia
31%
Hypophosphatemia
29%
Anorexia
29%
Hypokalemia
27%
Abdominal pain/cramping
22%
Hypomagnesemia
22%
Vomiting
20%
Hyperglycemia
20%
Hyperkalemia
20%
Lymphocyte count decrease
20%
Neuropathy-sensory
20%
Hypoalbuminemia
18%
Alanine aminotransferase increase
13%
Dyspnea
13%
Aspartate aminotransferase increase
11%
Creatinine
11%
Dehydration
11%
Dizziness
11%
Edema
9%
Thrombosis
9%
Alopecia
9%
Hypernatremia
9%
Weight loss
7%
Hearing impaired
7%
Constipation
7%
Dyspepsia
7%
Mood alteration/anxiety
7%
Taste disturbance
5%
Febrile neutropenia
5%
Dysphagia
5%
Pain, other
5%
Hypoglycemia
5%
Pharyngeal mucositis
4%
CNS/cerebrovascular ischemia
4%
Chest pain
4%
Hemorrhage, NOS
2%
Cardiovascular, other
2%
Hypotension
2%
Creatinine increased
2%
Gastrointestinal disorder
2%
Muscle weakness
2%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (18F-FDG PET-MRI)Experimental Treatment3 Interventions
Patients receive fludeoxyglucose F-18 IV over 1 minutes and then undergo PET-MRI over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose F-18 injection in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludeoxyglucose F-18
2018
Completed Phase 2
~550
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Positron Emission Tomography
2008
Completed Phase 2
~2260

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,332 Total Patients Enrolled
1 Trials studying Spinal Cord Tumors
128 Patients Enrolled for Spinal Cord Tumors
National Cancer Institute (NCI)NIH
13,606 Previous Clinical Trials
40,913,464 Total Patients Enrolled
Maria K Gule-MonroePrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Fludeoxyglucose F-18 (Contrast Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04219969 — N/A
Spinal Cord Tumors Research Study Groups: Diagnostic (18F-FDG PET-MRI)
Spinal Cord Tumors Clinical Trial 2023: Fludeoxyglucose F-18 Highlights & Side Effects. Trial Name: NCT04219969 — N/A
Fludeoxyglucose F-18 (Contrast Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04219969 — N/A

Frequently Asked Questions

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

Are there still opportunities to join this experiment?

"Affirmative. Referencing clinicaltrials.gov, it appears that the recruitment period for this trial began on September 21st 2018 and was last updated in August 18th 2022. The study is looking to select 20 participants from 1 medical centre."

Answered by AI

How many individuals are currently partaking in this medical experiment?

"Affirmative. According to the information published on clinicaltrials.gov, this trial is currently recruiting patients and has been since September 21st 2018. As of August 18th 2022, it requires 20 individuals at 1 medical facility to take part in the study."

Answered by AI
~3 spots leftby Mar 2025