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Imaging Techniques for Brain Tumor
Phase 1
Recruiting
Led By Sadek Nehmeh, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documentation of a suspected HGG diagnosis based on clinical and MRI findings
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial is testing new imaging techniques to see if they can predict how well standard cancer treatments will work on a patient's specific tumor.
Who is the study for?
This trial is for adults over 18 suspected to have High-Grade Glioma (HGG) based on clinical assessments and MRI results. It's not suitable for pregnant or breastfeeding individuals, or those who can't undergo PET scans due to conditions like claustrophobia.
What is being tested?
The study tests two PET imaging techniques: FMISO PET, which checks if tumor cells are lacking oxygen, and FLT PET, which examines cell growth. These will be compared with tissue biomarkers of hypoxia and proliferation to improve cancer treatment strategies.
What are the potential side effects?
Since the interventions involve diagnostic imaging rather than drug treatments, side effects may include discomfort during the scan process or reactions related to the contrast agents used in PET scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of a high-grade glioma is based on clinical exams and MRI results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Quantitation of proliferation (FLT) by measuring Dyn PET
Quantitation of tumor hypoxia (FMISO) by measuring Dyn PET
Secondary study objectives
FMISO/FLT PET Metrics and Molecular Biomarkers of Tissue Hypoxia, Tissue Angiogenesis, and Tissue Proliferation
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%
Hypokalemia
29%
Anorexia
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%
Dehydration
11%
Creatinine
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%
Seizure
2%
Cardiovascular, other
2%
Muscle weakness
2%
Gastrointestinal disorder
2%
Hypotension
2%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I
Trial Design
1Treatment groups
Experimental Treatment
Group I: High Grade Glioma (HGG)Experimental Treatment2 Interventions
Thirty newly diagnosed treatment-naïve subjects with suspected HGG based on clinical presentation and MRI findings and undergoing surgical planning will be accrued in this study.
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,077 Previous Clinical Trials
1,320,637 Total Patients Enrolled
William Rhodes Center for GlioblastomaUNKNOWN
Sadek Nehmeh, PhDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis of a high-grade glioma is based on clinical exams and MRI results.I am 18 years old or older.You have a condition that makes it unsafe for you to have a PET scan, like claustrophobia.
Research Study Groups:
This trial has the following groups:- Group 1: High Grade Glioma (HGG)
Awards:
This trial has 1 awards, including:- 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.
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