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出境医 / 临床实验 / Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas
Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas
Study Description
Brief Summary:
This phase I trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in predicting tumor growth in patients with meningiomas. Giving Gallium Ga 68-DOTATATE before PET/CT scan may work better in predicting tumor growth in patients with meningiomas.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningioma | Procedure: Computed Tomography Radiation: Gallium Ga 68-DOTATATE Procedure: Positron Emission Tomography | Phase 1 |
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the ability of imaging with gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography/computed tomography (PET/CT).
II. To assess a metabolic response to radiation therapy in meningiomas as measured by a reduction in the tumor to background ratio of the maximum standardized uptake values (SUV) of the tumor compared to background brain parenchyma.
OUTLINE:
Patients receive gallium Ga 68-DOTATATE intravenously (IV) over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 12 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | A Pilot Study of 68Ga-Dotatate PET CT for Radiation Treatment Response Assessment in Meningiomas |
| Actual Study Start Date : | January 10, 2019 |
| Estimated Primary Completion Date : | September 1, 2022 |
| Estimated Study Completion Date : | September 1, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Diagnostic (gallium Ga 68-DOTATATE PET/CT)
Patients receive gallium Ga 68-DOTATATE IV over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.
|
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
Radiation: Gallium Ga 68-DOTATATE Given IV
Other Names:
Procedure: Positron Emission Tomography Undergo PET/CT
Other Names:
|
Outcome Measures
Primary Outcome Measures :
- Imaging with Gallium Ga 68-DOTATATE [ Time Frame: Up to 1 year ]Lesions will be defined based on areas of T1 post contrast enhancement as assessed by magnetic resonance imaging (MRI). The largest bidimension measurements of the lesion on post-contrast T1 weighted magnetic resonance (MR) imaging will be recorded. Regions of interest (ROI) analysis of these regions of abnormal enhancement will be used to assess the max standard uptake values (SUV) of the lesion (tumor) as well as adjacent normal appearing brain parenchyma (background). These calculations will be repeated on the post-treatment scan as well as calculations for tumor to background (T/B) ratios.
- Metabolic response to radiation therapy [ Time Frame: Up to 1 year ]Will be measured by a reduction in the tumor to background ratio of the maximum SUV of the tumor compared to background brain parenchyma.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Any meningioma with at least 10 mm measurable residual disease
- Planned radiation therapy for meningioma
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Neurofibromatosis type 1 or 2
- Pregnant
- Contraindication to magnetic resonance (MR) imaging
- Body weight greater than 400 pounds (lbs) (181.4kg)
Contacts and Locations
Contacts
| Contact: Jason M Johnson | 713-792-8443 | jjohnson12@mdanderson.org |
Locations
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jason M. Johnson 713-792-8443 | |
| Principal Investigator: Jason M. Johnson | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Jason M Johnson | M.D. Anderson Cancer Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | February 1, 2019 | ||||
| First Posted Date ICMJE | May 16, 2019 | ||||
| Last Update Posted Date | February 13, 2020 | ||||
| Actual Study Start Date ICMJE | January 10, 2019 | ||||
| Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas | ||||
| Official Title ICMJE | A Pilot Study of 68Ga-Dotatate PET CT for Radiation Treatment Response Assessment in Meningiomas | ||||
| Brief Summary | This phase I trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in predicting tumor growth in patients with meningiomas. Giving Gallium Ga 68-DOTATATE before PET/CT scan may work better in predicting tumor growth in patients with meningiomas. | ||||
| Detailed Description |
PRIMARY OBJECTIVES: I. To assess the ability of imaging with gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography/computed tomography (PET/CT). II. To assess a metabolic response to radiation therapy in meningiomas as measured by a reduction in the tumor to background ratio of the maximum standardized uptake values (SUV) of the tumor compared to background brain parenchyma. OUTLINE: Patients receive gallium Ga 68-DOTATATE intravenously (IV) over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE | Meningioma | ||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: Diagnostic (gallium Ga 68-DOTATATE PET/CT)
Patients receive gallium Ga 68-DOTATATE IV over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
12 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 1, 2022 | ||||
| Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03953131 | ||||
| Other Study ID Numbers ICMJE | 2018-0659 NCI-2019-00214 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0659 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| PRS Account | M.D. Anderson Cancer Center | ||||
| Verification Date | February 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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