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Radioactive Substance

[18F]DASA-23 PET Scan for Brain Tumor

Phase 1

Waitlist Available

Led By Guido A Davidzon, MD

Research Sponsored by Guido A. Davidzon, MD, SM

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of initial diagnosis up to 2 years

Awards & highlights

Study Summary

This trial is studying how well a radioactive substance and a PET scan can detect a specific protein in people with brain tumors or cancer that has returned, and in healthy volunteers.

Who is the study for?

Adults with good organ function and specific blood levels, able to move with minimal help, can consent, and for some parts of the trial have a brain tumor or recurrent glioblastoma. Excludes those allergic to adhesives or gadolinium, severe illnesses, MRI-incompatible implants, kidney disease in healthy volunteers, pregnant/nursing women.Check my eligibility

What is being tested?

[18F]DASA-23 combined with PET scans is being tested to see how well it shows pyruvate kinase M2 activity in patients' brains. This could help understand brain tumor metabolism better in those with intracranial tumors or recurrent glioblastoma as well as healthy individuals.See study design

What are the potential side effects?

Potential side effects may include reactions related to the radioactive substance [18F]DASA-23 such as discomfort at injection site or allergic reactions. The PET scan procedure itself is generally safe but may pose risks for people who are claustrophobic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of initial diagnosis up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of initial diagnosis up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of initial diagnosis up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in [18F]DASA-23 PET scan signal in patients with suspected recurrent glioblastoma

Secondary outcome measures

Accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.

Overall survival in patients with suspected recurrent glioblastoma

Progression-free survival in patients with suspected recurrent glioblastoma

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group III ([18F]DASA-23, PET)Experimental Treatment2 Interventions

Patients with at least a 1cm3 contrast-enhancing lesion suspicious for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM) on a standard-of-care (SOC) brain MRI scan. If the patient undergoes a biopsy or resection for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM) then the remaining contrast-enhancing lesion is at least 1cm3 in size on the post-operative scan. These patients will undergo one [18F]DASA 23 PET/MRI scan before the initiation of therapy, and a second/final [18F]DASA 23 PET/MRI scan within 2-6 weeks after initiation of therapy for their GBM.

Group II: Group II ([18F]DASA-23, PET)Experimental Treatment2 Interventions

Intracranial tumor participants receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes.

Group III: Group IV ([18F]DASA-23, PET)Active Control2 Interventions

Healthy volunteers receive [18F]DASA-23 IV and undergo brain PET/MRI brain scan for 60 mins

Group IV: Group I ([18F]DASA-23, PET)Active Control2 Interventions

Healthy volunteers receive [18F]DASA-23 IV and undergo brain PET scan over 15 minutes and 4 vertex-to-toe PET scans over 30 minutes each.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorine F 18 DASA-23

2018

Completed Phase 1

~30

Positron Emission Tomography

2008

Completed Phase 2

~2240

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Guido A. Davidzon, MD, SMLead Sponsor

1 Previous Clinical Trials

Guido A. Davidzon, MD, MSLead Sponsor

1 Previous Clinical Trials

Guido A Davidzon, MDPrincipal InvestigatorStanford Cancer Institute Palo Alto

Frequently Asked Questions

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

Is it possible to join this experiment at present?

"As per the documentation on clinicaltrials.gov, this study is actively enrolling individuals. Initially posted in April 2018 and recently updated October 2022, the trial seeks to include eligible patients."

Answered by AI

Has Fluorine F 18 DASA-23 obtained the necessary authorization from the FDA?

"The safety of Fluorine F 18 DASA-23 was rated a 1 due to the limited evidence collected during its Phase 1 trial, which indicates that efficacy and safety have yet to be established."

Answered by AI

How many participants are expected to enroll in the trial?

"Affirmative, the clinicaltrials.gov listing outlines that this medical investigation is still open for enrolment. It was initially posted on April 23rd 2018 and latest update occurred October 24th 2022; 25 patients are needed at single site to complete the trial."

Answered by AI

Recent research and studies

Molecular Imaging and BiologyJournal

Evaluation of Glycolytic Response to Multiple Classes of Anti-glioblastoma Drugs by Noninvasive Measurement of Pyruvate Kinase M2 Using [18F]DASA-23

Beinat, Corinne, Chirag B. Patel, Yuanyang Xie, and Sanjiv S. Gambhir. 2019. “Evaluation of Glycolytic Response to Multiple Classes of Anti-glioblastoma Drugs by Noninvasive Measurement of Pyruvate Kinase M2 Using [18F]DASA-23”. Molecular Imaging and Biology. Springer Science and Business Media LLC. doi:10.1007/s11307-019-01353-2.

European Journal of Nuclear Medicine and Molecular ImagingJournal

Human Biodistribution and Radiation Dosimetry of [18F]DASA-23, a PET Probe Targeting Pyruvate Kinase M2

Beinat, Corinne, Chirag B. Patel, Tom Haywood, Bin Shen, Lewis Naya, Harsh Gandhi, Dawn Holley, et al.. 2020. “Human Biodistribution and Radiation Dosimetry of [18F]DASA-23, a PET Probe Targeting Pyruvate Kinase M2”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-020-04687-0.

clinicaltrials.govStudy

[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers

Guido A. Davidzon, MD, SM 2018. "[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03539731.