[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 |
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Recruitment Status :
Recruiting
First Posted : May 29, 2018
Last Update Posted : October 25, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Subject Intracranial Neoplasm Glioblastoma | Drug: Fluorine F 18 DASA-23 Procedure: Positron Emission Tomography | Phase 1 |
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 4 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: Subjects with glioblastoma will receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes. 15-minute vertex-to-thigh PET for Part 3 patients, Participants undergo second PET scan 7 days after the initiation of therapy.
GROUP IV: Healthy volunteers will undergo the same procedures as the healthy volunteers in Group I with the following exceptions:
Group IV healthy volunteers will undergo a 60-minute PET/MRI brain scan instead of a 15-minute PET/MRI brain scan.
Group IV healthy volunteers will not undergo any vertex-to-toe PET scans.
After completion of study treatment, intracranial tumor and recurrent glioblastoma participants are followed up every 3 months for 12 months.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 25 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential 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 : | December 30, 2022 |
| Estimated Study Completion Date : | December 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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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.
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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:
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Experimental: Group III ([18F]DASA-23, PET)
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.
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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:
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Active Comparator: Group IV ([18F]DASA-23, PET)
Healthy volunteers receive [18F]DASA-23 IV and undergo brain PET/MRI brain scan for 60 mins
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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:
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- 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.
- 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.
- 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
- 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.
- 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.
- 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 |
Inclusion Criteria:
Age ≥18 years old.
2. Adequate organ function (obtained within 14 days prior to PET scan [Part 1, Part 2, and Part 3 ONLY] or within 28 days prior to PET scan [Part 4 ONLY]) as evidenced by:
- ANC ≥ 1.5 X 10^9/L w/o myeloid growth factor support for 7 d preceding lab assessment
- 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
- Platelet count ≥ 100 X 10^9/L w/o blood transfusions for 7 d preceding lab assessment
- Bilirubin ≤ 1.5 X ULN except for pts w/ documented history of Gilbert's disease
- ALT and AST ≤ 2.5 X ULN
- Alkaline phosphatase (AP) ≤ 3 X ULN
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Women of childbearing potential (WCBP): negative serum pregnancy test
3. Ability to stand up and climb two steps with minimal assistance.
4. Ability to understand and the willingness to sign a written informed consent document.
5. (Part 2, intracranial tumor patients ONLY) (a) Radiographical or pathological evidence of newly-diagnosed intracranial tumor that is status-pre surgical resection, or (b) Radiographical or pathological evidence of progressive/recurrent intracranial tumor, (c) Question of pseudoprogression vs. true progression on most recent standard-of-care brain MRI, or (d) Evidence on the most recent standard-of-care brain MRI scan of intracranial metastasis/metastases in a patient with known extracranial primary cancer.
6. (Part 3, GBM patients ONLY) Any patient with at least a 1cm3 contrast-enhancing lesion suspicious for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) 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, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) then the remaining contrast-enhancing lesion is at least 1cm3 in size on the post-operative scan.
7. (Part 3, GBM patients ONLY) Life expectancy of ≥ 6 months.
Exclusion Criteria:
- Known allergy to adhesive tapes or other skin adhesives used in medical care
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Subjects with the following co-morbid disease or incurrent illness:
- With 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 contra-indicated for MRI
- Bleeding disorder
- Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.
- (Healthy volunteers ONLY - Part 1 and Part 4) prior or current malignancy
- (Healthy volunteers ONLY - Part 1 and Part 4) 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, GBM patients ONLY) Has already begun therapy, prior to the first of two [18F]DASA-23 PET/MRI scans.
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
| United States, California | |
| Stanford University, School of Medicine | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Lewis Naya 650-724-9363 lnaya@stanford.edu | |
| Principal Investigator: Guido A Davidzon, M.D. | |
| Principal Investigator: | Guido A Davidzon, MD | Stanford Cancer Institute Palo Alto |
| Responsible Party: | Guido A. Davidzon, MD, SM, Clinical Associate Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT03539731 |
| Other Study ID Numbers: |
BRN0038 NCI-2018-00826 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 44597 ( Other Identifier: Stanford IRB ) |
| First Posted: | May 29, 2018 Key Record Dates |
| Last Update Posted: | October 25, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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