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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00055 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Funding
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This pilot clinical trial studies how well Gallium-68 prostate specific membrane antigen positron emission tomography (PET) work in diagnosing patients with thyroid cancer. Diagnostic procedures, such as 68Ga-PSMA PET, may more accurately diagnose thyroid cancer and find out how far the disease has spread.
PRIMARY OBJECTIVES:
I. To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET imaging in patients with thyroid cancer.
SECONDARY OBJECTIVES:
I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET in thyroid cancer compared to areas identified as tumor by radioiodine uptake (in well-differentiated cancers) or fludeoxyglucose F-18 (18F-FDG) uptake (in poorly differentiated and/or radioiodine-negative cancers).
II. To determine and compare the sensitivity and specificity of 68Ga-PSMA PET to (18F-FDG) PET and/or radioiodine scintigraphy.
TERTIARY OBJECTIVES:
I. To determine if 68Ga-PSMA PET uptake is related to tumor differentiation and PSMA staining in tissue pathology when available.
II. To determine the correlation between standardized uptake value maximum (SUVmax) of target thyroid cancer lesions on 68Ga-PSMA PET and serum thyroglobulin levels.
OUTLINE:
Participants receive 68Ga-PSMA intravenously (IV) over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Experimental | Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gallium Ga 68-labeled PSMA-11 | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of 68Ga PSMA-11 PET-positive Lesions | The number of 68Ga PSMA-11 PET-positive lesions detected by staging scans will be descriptively reported. | Up to 24 months |
| Number of Overall Detected Thyroid Cancer Lesions | The number of overall thyroid cancer lesions detected by standard staging scans will be descriptively reported | Up to 24 months |
| Mean Standardized Uptake Value Maximum of Gallium-68 PSMA (SUVmax) | The mean and standard deviation for SUVmax across all lesions across all patients will be reported. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers | For each lesion detected on 18F-FDG PET or radioiodine scintigraphy (131I), the presence or absence of 68Ga-PSMA-11 uptake will be reviewed and tabulated. Presence on either 131I and 18F-FDG will be considered true positive disease. If additional lesions are detected on 68Ga-PSMA-11 as compared to 18F-FDG or 131I, the lesions will be characterized as either true or false positives in comparison to the appearance of the lesion on conventional imaging (thyroid ultrasound, CT and MRI). The gold standard for an individual lesion will be FDG or 131I, if the individual lesion is positive on either imaging study. If the lesions are not seen on either FDG or 131I, then consensus reading of conventional imaging will be performed to determine true and false positives lesions. Point estimate of the true positive rate will be calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Flavell, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan. Gallium Ga 68-labeled PSMA-11: Given IV Magnetic Resonance Imaging: Undergo MRI in combination with PET Positron Emission Tomography (PET): Undergo PET in combination with MRI |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan. Gallium Ga 68-labeled PSMA-11: Given IV Magnetic Resonance Imaging: Undergo MRI in combination with PET Positron Emission Tomography (PET): Undergo PET in combination with MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of 68Ga PSMA-11 PET-positive Lesions | The number of 68Ga PSMA-11 PET-positive lesions detected by staging scans will be descriptively reported. | One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing [68Ga]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability | Posted | Number | lesions | Up to 24 months |
|
Up to 6 months
Only grade 3 and higher adverse events were recorded
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan. Gallium Ga 68-labeled PSMA-11: Given IV Magnetic Resonance Imaging: Undergo MRI in combination with PET Positron Emission Tomography (PET): Undergo PET in combination with MRI |
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Study closed earlier than expected due to lack of funding. Due to the small sample size, comparative sub-group analyses could not be performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Flavell, MD PhD | University of California, San Francisco | 877-827-3222 | Robert.Flavell@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2019 | May 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI in combination with PET |
|
|
| Positron Emission Tomography (PET) | Procedure | Undergo PET in combination with MRI |
|
|
| Up to 24 months |
| Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers | Specificity is the agents ability to exclude the disease when the disease is absent. For each lesion detected on 18F-FDG PET or radioiodine scintigraphy (131I), the presence or absence of 68Ga-PSMA-11 uptake will be reviewed and tabulated. Presence on either 131I and 18F-FDG will be considered true positive disease. If additional lesions are detected on 68Ga-PSMA-11 as compared to 18F-FDG or 131I, the lesions will be characterized as either true or false positives in comparison to the appearance of the lesion on conventional imaging (thyroid ultrasound, CT and MRI). The gold standard for an individual lesion will be FDG or 131I, if the individual lesion is positive on either imaging study. If the lesions are not seen on either FDG or 131I, then consensus reading of conventional imaging will be performed to determine true and false positives lesions. Point estimate of the true negative rate will be reported. | Up to 24 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years from initial diagnosis to study imaging | Median | Full Range | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Overall Detected Thyroid Cancer Lesions | The number of overall thyroid cancer lesions detected by standard staging scans will be descriptively reported | One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing [68Ga]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability | Posted | Number | lesions | Up to 24 months |
|
|
|
| Primary | Mean Standardized Uptake Value Maximum of Gallium-68 PSMA (SUVmax) | The mean and standard deviation for SUVmax across all lesions across all patients will be reported. | One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing [68Ga]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability | Posted | Mean | Standard Deviation | Ratio | Up to 6 months |
|
|
|
| Secondary | Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers | For each lesion detected on 18F-FDG PET or radioiodine scintigraphy (131I), the presence or absence of 68Ga-PSMA-11 uptake will be reviewed and tabulated. Presence on either 131I and 18F-FDG will be considered true positive disease. If additional lesions are detected on 68Ga-PSMA-11 as compared to 18F-FDG or 131I, the lesions will be characterized as either true or false positives in comparison to the appearance of the lesion on conventional imaging (thyroid ultrasound, CT and MRI). The gold standard for an individual lesion will be FDG or 131I, if the individual lesion is positive on either imaging study. If the lesions are not seen on either FDG or 131I, then consensus reading of conventional imaging will be performed to determine true and false positives lesions. Point estimate of the true positive rate will be calculated. | One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing [68Ga]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability | Posted | Number | proportion of participants | Up to 24 months |
|
|
|
| Secondary | Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers | Specificity is the agents ability to exclude the disease when the disease is absent. For each lesion detected on 18F-FDG PET or radioiodine scintigraphy (131I), the presence or absence of 68Ga-PSMA-11 uptake will be reviewed and tabulated. Presence on either 131I and 18F-FDG will be considered true positive disease. If additional lesions are detected on 68Ga-PSMA-11 as compared to 18F-FDG or 131I, the lesions will be characterized as either true or false positives in comparison to the appearance of the lesion on conventional imaging (thyroid ultrasound, CT and MRI). The gold standard for an individual lesion will be FDG or 131I, if the individual lesion is positive on either imaging study. If the lesions are not seen on either FDG or 131I, then consensus reading of conventional imaging will be performed to determine true and false positives lesions. Point estimate of the true negative rate will be reported. | One patient with qualifying FDG PET/CT underwent surgical procedures prior to undergoing [68Ga]Ga-PSMA-11 PET/MRI and was therefore excluded from the analysis due to lack of comparability | Posted | Number | proportion of participants | Up to 24 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |