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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

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,265 Total Patients Enrolled

William Rhodes Center for GlioblastomaUNKNOWN

Sadek Nehmeh, PhDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

18F-FMISO PET Clinical Trial Eligibility Overview. Trial Name: NCT04309552 — Phase 1

Brain Tumor Research Study Groups: High Grade Glioma (HGG)

Brain Tumor Clinical Trial 2023: 18F-FMISO PET Highlights & Side Effects. Trial Name: NCT04309552 — Phase 1

18F-FMISO PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT04309552 — Phase 1

Frequently Asked Questions

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

What is the current intake capacity for this medical experiment?

"Indeed, the information hosted on clinicaltrials.gov suggests that this trial is actively enrolling patients as of now. It was first posted February 1st 2021 and its most recent edit occurred April 10th 2022. The study seeks to recruit a total of 30 participants from one medical facility."

Answered by AI

Are there any vacancies for participants in this medical research?

"Affirmative. The information available on clinicaltrials.gov attests to this medical trial's recruitment status; it was initially posted in February 2021 and recently modified April 2022. For the duration of the study, 30 participants will be sought from a single location."

Answered by AI

Does this research permit the enrollment of individuals over 55 years old?

"Patients between 18 and 100 years old are considered eligible for this medical trial. There is a total of 172 trials targeting younger patients, while 343 studies focus on those over 65."

Answered by AI

What risks does 18F-FMISO PET present for participants?

"Due to the lack of data supporting safety and efficacy, 18F-FMISO PET was assigned a score of 1 on our scale. This is consistent with it being in Phase I clinical trials."

Answered by AI

To what demographic is this trial open?

"At the moment, this medical trial is looking for 30 people aged between 18 and 100 that are currently suffering from glioma. Additionally, all participants must be male or female and above legal age of consent."

Answered by AI

Are there any recorded precedents of 18F-FMISO PET?

"Currently, there are 4 studies involving 18F-FMISO PET imaging in operation. The majority of these research endeavors are located in Duarte, California; however there are a few other medical centres that have joined the initiative. As well as this, no trials for this technology have reached Phase 3 yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tumor Hypoxia and Proliferation in Patients With High-Grade Glioma

2021. "Tumor Hypoxia and Proliferation in Patients With High-Grade Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04309552.

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