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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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Quantitation of proliferation (FLT) by measuring Dyn PET

Quantitation of tumor hypoxia (FMISO) by measuring Dyn PET

Secondary outcome measures

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 • 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

Thrombosis

Alopecia

Hypernatremia

Weight loss

Hearing impaired

Constipation

Dyspepsia

Mood alteration/anxiety

Taste disturbance

Febrile neutropenia

Dysphagia

Pain, other

Hypoglycemia

Pharyngeal mucositis

Hemorrhage, NOS

CNS/cerebrovascular ischemia

Chest pain

Gastrointestinal disorder

Cardiovascular, other

Seizure

Hypotension

Muscle weakness

Creatinine increased

100%

80%

60%

40%

20%

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.

0 / 1Eligibility criteria met