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

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ClinicalTrials.gov Identifier: NCT03539731
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

Brief Summary:
This phase I trial studies how well [18F]DASA-23 and positron emission tomography (PET) scan work in evaluating pyruvate kinase M2 (PKM2) expression in patients with intracranial tumors or recurrent glioblastoma and healthy volunteers. PKM2 regulates brain tumor metabolism, a key factor in glioblastoma growth. [18F]DASA-23 is a radioactive substance with the ability to monitor PKM2 activity. A PET scan is a procedure in which a small amount of a radioactive substance, such as [18F]DASA-23, is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the substance is used. Tumor cells usually pick up more of these radioactive substances, allowing them to be found. Giving [18F]DASA-23 with a PET scan may help doctors evaluate PKM2 expression in healthy volunteers and in participants with intracranial tumors or recurrent glioblastoma.

Condition or disease Intervention/treatment Phase
Healthy Subject Intracranial Neoplasm Recurrent Glioblastoma Drug: Fluorine F 18 DASA-23 Procedure: Positron Emission Tomography Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine whether the fluorine F 18 DASA-23 ([18F]DASA 23) PET scan signal change from pre-therapy to one week after initiation of therapy can predict the tumor's responsiveness to therapy and 6 month progression free survival (PFS6), in suspected recurrent glioblastoma.

SECONDARY OBJECTIVES:

I. Determine the sensitivity, specificity, and accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.

II. Determine whether the [18F]DASA-23 PET scan signal change from pre therapy to one week after initiation of therapy can predict progression free survival (PFS) and overall survival (OS), in suspected recurrent glioblastoma.

OUTLINE: Participants are assigned to 1 of 3 groups.

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

GROUP II: 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: Recurrent glioblastoma participants receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes. Participants undergo second PET scan 7 days after the initiation of therapy.

After completion of study treatment, intracranial tumor and recurrent glioblastoma participants are followed up every 3 months for 12 months.


Study Type : Interventional
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I Study of [18F]DASA-23 as a PET Tracer for Evaluating Pyruvate Kinase M2 (PKM2) Expression in Healthy Volunteers and in Patients With Intracranial Tumors
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : April 23, 2020
Estimated Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Active Comparator: Group I ([18F]DASA-23, PET)
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.
Drug: Fluorine F 18 DASA-23
Given IV
Other Name: [18F]DASA-23; [18F]DASA23; 18F-DASA-23; 1-((2-Fluoro-6-[18F]fluorophenyl)sulfonyl)-4-((4-methoxyphenyl)sulfonyl)piperazine; F18-labeled Pyruvate Kinase M2 Inhibitor DASA-23; F18-labeled PKM2 Inhibitor

Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Experimental: Group II ([18F]DASA-23, PET)
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.
Drug: Fluorine F 18 DASA-23
Given IV
Other Name: [18F]DASA-23; [18F]DASA23; 18F-DASA-23; 1-((2-Fluoro-6-[18F]fluorophenyl)sulfonyl)-4-((4-methoxyphenyl)sulfonyl)piperazine; F18-labeled Pyruvate Kinase M2 Inhibitor DASA-23; F18-labeled PKM2 Inhibitor

Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Experimental: Group III ([18F]DASA-23, PET)
Recurrent glioblastoma participants receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes. Participants undergo second PET scan 7 days after the initiation of therapy.
Drug: Fluorine F 18 DASA-23
Given IV
Other Name: [18F]DASA-23; [18F]DASA23; 18F-DASA-23; 1-((2-Fluoro-6-[18F]fluorophenyl)sulfonyl)-4-((4-methoxyphenyl)sulfonyl)piperazine; F18-labeled Pyruvate Kinase M2 Inhibitor DASA-23; F18-labeled PKM2 Inhibitor

Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Change in [18F]DASA-23 PET scan signal in patients with suspected recurrent glioblastoma [ Time Frame: From pre-treatment to one week after initiation of treatment ]
    Response to treatment is based on the response assessment in neuro-oncology (RANO) criteria. Each patient will be dichotomized into responding (yes) or not responding (no) to treatment based on RANO criteria. The [18F]DASA-23 PET scan signal will be calculated according to the European Organization for Research and Treatment of Cancer (EORTC) response criteria guidelines and reported as median and range, both for the entire cohort as well as separately for the responder and non-responder subgroups. The Mann-Whitney test of [18F]DASA-23 PET scan signal between responders and non-responders will be performed.


Secondary Outcome Measures :
  1. Sensitivity of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors. [ Time Frame: Time of the [18F]DASA-23 PET scan ]
    Sensitivity will be reported as a percentage with 95% confidence interval.

  2. Specificity of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors. [ Time Frame: Time of the [18F]DASA-23 PET scan ]
    Specificity will be reported as a percentage with 95% confidence interval

  3. Accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors. [ Time Frame: Time of the [18F]DASA-23 PET scan ]
    Accuracy will be reported as a percentage with 95% confidence interval.

  4. Progression-free survival in patients with suspected recurrent glioblastoma [ Time Frame: Time from diagnosis up to 1 year ]
    The percent change in SUV from the pre-treatment [18F]DASA-23 PET scan to the post-treatment [18F]DASA23 PET scan will be calculated. Patients will be divided into two groups based on whether their percent change in SUV is above or below the median. Kaplan-Meier curves for the two groups will be plotted and a log-rank test for difference in progression-free survival will be performed. A Cox proportional-hazards regression of progression-free survival on group will be performed. Progression-free survival will be reported as median survival time, with range.

  5. Overall survival in patients with suspected recurrent glioblastoma [ Time Frame: From time of initial diagnosis up to 2 years ]
    The percent change in SUV from the pre-treatment [18F]DASA-23 PET scan to the post-treatment [18F]DASA23 PET scan will be calculated. Patients will be divided into two groups based on whether their percent change in SUV is above or below the median. Kaplan-Meier curves for the two groups will be plotted and a log-rank test for difference in overall survival will be performed. A Cox proportional-hazards regression of overall survival on group will be performed. Overall survival will be reported as median survival time, with range.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Absolute neutrophil count (ANC) >= 1.5 X 10^9/L without (w/o) myeloid growth factor support for 7 days preceding lab assessment, obtained within 14 days prior to PET scan
  • Hemoglobin (Hgb) >= 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb is corrected to >= 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan, obtained within 14 days prior to PET scan
  • Platelet count >= 100 X 10^9/L w/o blood transfusions for 7 days preceding lab assessment, obtained within 14 days prior to PET scan
  • Bilirubin = < 1.5 X upper limit of normal (ULN) except for patients (pts) with (w/) documented history of Gilbert?s disease, obtained within 14 days prior to PET scan
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 X ULN, obtained within 14 days prior to PET scan
  • Alkaline phosphatase (AP) =< 3 X ULN, obtained within 14 days prior to PET scan
  • Women of childbearing potential (WCBP): negative serum pregnancy test, obtained within 14 days prior to PET scan
  • Karnofsky performance status (KPS) >= 60 (Parts 2 [intracranial tumor patients] and 3 [recurrent glioblastoma (GBM) patients] ONLY)
  • Ability to understand and the willingness to sign a written informed consent document
  • (Part 2, intracranial tumor patients ONLY): Radiographical or pathological evidence of an intracranial tumor
  • (Part 3, suspected recurrent GBM patients ONLY): Any patient with histopathologically proven GBM who, on a standard of care surveillance brain magnetic resonance imaging (MRI), has an imaging change suspicious for GBM recurrence, and whose treatment plan for the recurrence does not include surgery
  • (Part 3, suspected recurrent GBM patients ONLY): Life expectancy of >= 6 months

Exclusion Criteria:

  • Known allergy to adhesive tapes or other skin adhesives used in medical care
  • Known cirrhosis diagnosed with Child Pugh class A or higher liver disease
  • Severe/uncontrolled inter current illness within the previous 28 days prior to PET scan
  • Patients who have implantable devices that are contraindicated for MRI
  • Bleeding disorder
  • Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation
  • EXCLUSION - HEALTHY VOLUNTEERS: Prior or current malignancy
  • EXCLUSION - HEALTHY VOLUNTEERS: Known kidney disease
  • Pregnant or nursing participants
  • History of allergic reactions to gadolinium-based MRI contrast agent
  • (Part 2, intracranial tumor patients ONLY): Other chemotherapy (besides what is being used to treat the intracranial tumor)
  • (Part 3, suspected recurrent GBM patients ONLY): Has already begun non surgical therapy for any recurrence, prior to the first [18F]DASA 23 PET/MRI scan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539731


Locations
United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Hari Priya M. Yerraballa    650-724-9363    yhpriya@stanford.edu   
Principal Investigator: Sanjiv Gambhir         
Sponsors and Collaborators
Sanjiv Sam Gambhir
Investigators
Principal Investigator: Sanjiv Gambhir Stanford Cancer Institute Palo Alto

Responsible Party: Sanjiv Sam Gambhir, Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research and Professor, by courtesy, of Materials Science and Engineering, Stanford University
ClinicalTrials.gov Identifier: NCT03539731     History of Changes
Other Study ID Numbers: BRN0038
NCI-2018-00826 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
44597 ( Other Identifier: Stanford IRB )
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Glioblastoma
Astrocytoma
Glioma
Central Nervous System Diseases
Nervous System Diseases