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Imaging Agent
Dual Time Point FDG PET/MRI Scan for Brain Cancer
Phase 4
Recruiting
Led By Dawid Schellingerhout
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
Planned surgery or radiation to the metastases
Pre-treatment adult patients with any solid organ metastasis and at least three intraaxial brain metastases including at least one enhancing > 10 mm lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of a year
Awards & highlights
Study Summary
This trial looks at if delaying a PET/MRI scan after injecting FDG helps doctors better see the difference between healthy and unhealthy tissue.
Who is the study for?
This trial is for adults with cancer that has spread to the brain, who are planning surgery or radiation. They must be able to undergo PET/MRI scans and have at least one large enough detectable lesion in the brain. Pregnant women, individuals allergic to FDG or gadolinium contrast agents, or those with severe kidney issues cannot participate.Check my eligibility
What is being tested?
The study is testing whether delaying a PET/MRI scan after injecting an imaging agent called FDG can improve the distinction between healthy and unhealthy tissue in patients with brain metastases from other solid cancers.See study design
What are the potential side effects?
Potential side effects may include reactions to the FDG injection like rash, itching, or discomfort. Gadolinium contrast used during MRI might cause nausea, headache, pain at injection site or allergic reactions in some people.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery or radiation therapy for cancer that has spread.
Select...
I have cancer that has spread to my brain with at least one large tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of a year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of a year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
assess the optimal fludeoxyglucose F-18 (fluorodeoxyglucose) positron emission tomography (FDG PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma
Side effects data
From 2011 Phase 2 trial • 55 Patients • NCT0006237465%
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%
Hemorrhage, NOS
4%
CNS/cerebrovascular ischemia
4%
Chest pain
2%
Gastrointestinal disorder
2%
Cardiovascular, other
2%
Seizure
2%
Hypotension
2%
Muscle weakness
2%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (fludeoxyglucose F-18, PET/MRI)Experimental Treatment3 Interventions
Patients receive fludeoxyglucose F-18 IV over approximately 1 minute and undergo a PET/MRI scan over 70 minutes. Within 5 hours of receiving fludeoxyglucose F-18, patients undergo a repeat PET/MRI scan over 30 minutes. Scans take place within 2 weeks before scheduled surgery and within 4-6 weeks after radiation treatment.
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
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,454 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,421 Total Patients Enrolled
Dawid SchellingerhoutPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to FDG or gadolinium contrast agents.My kidney function is reduced with a GFR less than 30.I am scheduled for surgery or radiation therapy for cancer that has spread.I have cancer that has spread to my brain with at least one large tumor.I have a brain lesion and a confirmed history of cancer spread outside the brain.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (fludeoxyglucose F-18, PET/MRI)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently taking part in this experiment?
"Yes, the latest information on clinicaltrials.gov indicates that this trial is actively recruiting patients. This medical study was initially posted on August 3rd 2018 and has since been updated as recently as September 27th 2022. Currently, a total of 20 participants are needed for one location."
Answered by AI
Has Fludeoxyglucose F-18 been given regulatory approval?
"Fludeoxyglucose F-18 has been approved, so it was given a satisfactory score of 3 in our safety analysis."
Answered by AI
Are there any slots available to enroll in this clinical experiment?
"Indeed, the clinicaltrials.gov website indicates that this research is presently recruiting participants. It was first uploaded on August 3rd 2018 and has been amended as recently as September 27th 2022. This investigation requires 20 volunteers from a single medical centre to take part."
Answered by AI
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