Healthy SubjectPhase 1NCT03539731
[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers
A Phase 1 study testing Fluorine F 18 DASA-23 and Positron Emission Tomography in people with Healthy Subject and Intracranial Neoplasm, run by Guido A. Davidzon, MD, SM at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Intracranial Neoplasm, Glioblastoma
- What is being tested?
- Fluorine F 18 DASA-23 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- ALT and AST ≤ 2.5 X ULN
- Alkaline phosphatase (AP) ≤ 3 X ULN
- 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.
Who cannot join
- Known allergy to adhesive tapes or other skin adhesives used in medical care
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Healthy Subject, Intracranial Neoplasm, Glioblastoma
- Being tested
- Fluorine F 18 DASA-23, Positron Emission Tomography
- Medical subject headings
- Brain Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorine F 18 DASA-23Drug
Also called [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
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET scan
| Study group | Role | What they receive |
|---|---|---|
| Group I ([18F]DASA-23, PET) | Active comparator | 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. Receives: Drug: Fluorine F 18 DASA-23; Procedure: Positron Emission Tomography |
| Group II ([18F]DASA-23, PET) | Experimental | 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. Receives: Drug: Fluorine F 18 DASA-23; Procedure: Positron Emission Tomography |
| Group III ([18F]DASA-23, PET) | Experimental | 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. Receives: Drug: Fluorine F 18 DASA-23; Procedure: Positron Emission Tomography |
| Group IV ([18F]DASA-23, PET) | Active comparator | Healthy volunteers receive [18F]DASA-23 IV and undergo brain PET/MRI brain scan for 60 mins Receives: Drug: Fluorine F 18 DASA-23; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in [18F]DASA-23 PET scan signal in patients with suspected recurrent glioblastoma
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.
Measured: From pre-treatment to one week after initiation of treatment
Secondary outcomes (5)
Sensitivity of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
Sensitivity will be reported as a percentage with 95% confidence interval.
Measured: Time of the [18F]DASA-23 PET scan
Specificity of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
Specificity will be reported as a percentage with 95% confidence interval
Measured: Time of the [18F]DASA-23 PET scan
Accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
Accuracy will be reported as a percentage with 95% confidence interval.
Measured: Time of the [18F]DASA-23 PET scan
Progression-free survival in patients with suspected recurrent glioblastoma
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.
Measured: Time from diagnosis up to 1 year
Overall survival in patients with suspected recurrent glioblastoma
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.
Measured: From time of initial diagnosis up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start23 Apr 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: study did not meet its objectives due to difficulties in enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guido A. Davidzon, MD, SM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guido A. Davidzon, MD, SM, Stanford University
- Investigators
- Guido A Davidzon, MD, Principal investigator, Stanford Cancer Institute Palo Alto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539731
- Sponsor's protocol ID
- IRB-44597
- Other IDs
- NCI-2018-00826, 44597
- Status last verified
- Aug 2024
- First submitted
- 16 May 2018
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Beinat C, Patel CB, Haywood T, Shen B, Naya L, Gandhi H, Holley D, Khalighi M, Iagaru A, Davidzon G, Gambhir SS. Human biodistribution and radiation dosimetry of [18F]DASA-23, a PET probe targeting pyruvate kinase M2. Eur J Nucl Med Mol Imaging. 2020 Aug;47(9):2123-2130. doi: 10.1007/s00259-020-04687-0. Epub 2020 Jan 15.
PubMed 31938892Beinat C, Patel CB, Xie Y, Gambhir SS. Evaluation of Glycolytic Response to Multiple Classes of Anti-glioblastoma Drugs by Noninvasive Measurement of Pyruvate Kinase M2 Using [18F]DASA-23. Mol Imaging Biol. 2020 Feb;22(1):124-133. doi: 10.1007/s11307-019-01353-2.
PubMed 30989436
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03539731
- Acronym / sponsor ID
- IRB-44597
- Conditions
- Healthy Subject, Intracranial Neoplasm, Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study did not meet its objectives due to difficulties in enrollment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Guido A. Davidzon, MD, SMUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I ([18F]DASA-23, PET) | Active comparator | Drug: Fluorine F 18 DASA-23, Procedure: Positron Emission TomographyHealthy 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. |
| Group II ([18F]DASA-23, PET) | Experimental | Drug: Fluorine F 18 DASA-23, Procedure: Positron Emission TomographyIntracranial 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 ([18F]DASA-23, PET) | Experimental | Drug: Fluorine F 18 DASA-23, Procedure: Positron Emission TomographyPatients 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 IV ([18F]DASA-23, PET) | Active comparator | Drug: Fluorine F 18 DASA-23, Procedure: Positron Emission TomographyHealthy volunteers receive [18F]DASA-23 IV and undergo brain PET/MRI brain scan for 60 mins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- Known allergy to adhesive tapes or other skin adhesives used in medical care
- Subjects with the following co-morbid disease or incurrent illness:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorine F 18 DASA-23Also: [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 InhibitorGiven IV | Drug | Group I ([18F]DASA-23, PET), Group II ([18F]DASA-23, PET), Group III ([18F]DASA-23, PET), Group IV ([18F]DASA-23, PET) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET scan | Procedure or surgery | Group I ([18F]DASA-23, PET), Group II ([18F]DASA-23, PET), Group III ([18F]DASA-23, PET), Group IV ([18F]DASA-23, PET) |
Primary outcome
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.
5 secondary outcomes
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
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
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
Progression-free survival in patients with suspected recurrent glioblastoma
Time frame: Time from diagnosis up to 1 year
Overall survival in patients with suspected recurrent glioblastoma
Time frame: From time of initial diagnosis up to 2 years
Results and safety
The study was stopped early (reason given: study did not meet its objectives due to difficulties in enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 31938892Beinat C, Patel CB, Haywood T, Shen B, Naya L, Gandhi H, Holley D, Khalighi M, Iagaru A, Davidzon G, Gambhir SS. Human biodistribution and radiation dosimetry of [18F]DASA-23, a PET probe targeting pyruvate kinase M2. Eur J Nucl Med Mol Imaging. 2020 Aug;47(9):2123-2130. doi: 10.1007/s00259-020-04687-0. Epub 2020 Jan 15.
- Derived from this study: PubMed 30989436Beinat C, Patel CB, Xie Y, Gambhir SS. Evaluation of Glycolytic Response to Multiple Classes of Anti-glioblastoma Drugs by Noninvasive Measurement of Pyruvate Kinase M2 Using [18F]DASA-23. Mol Imaging Biol. 2020 Feb;22(1):124-133. doi: 10.1007/s11307-019-01353-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido A Davidzon, MD principal investigator
Stanford Cancer Institute Palo Alto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluorine F 18 DASA-23 and Positron Emission Tomography in people with Healthy Subject and Intracranial Neoplasm, run by Guido A. Davidzon, MD, SM at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: study did not meet its objectives due to difficulties in enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539731, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.