Thyroid Gland Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Given IV
PROCEDUREMagnetic Resonance Imaging
Undergo MRI in combination with PET
PROCEDUREPositron Emission Tomography (PET)
Undergo PET in combination with MRI
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of thyroid cancer * Whole body 18F-FDG PET/computed tomography (CT) or I-131 scintigraphy within the past 90 days of the scheduled 68Ga-PSMA PET demonstrating uptake * Creatinine =\< 3.0 mg/dL * Ability to understand a written informed consent document, and the willingness to sign it
Exclusion criteria
* Patients who have had active infection within 15 days of study enrollment that may be considered to interfere with 68Ga-PSMA PET imaging by the study investigators * Patients who are unable to have placement of intravenous line access * Pregnant or breastfeeding women * Patients not capable of undergoing a PET/MRI study due to weight, claustrophobia, or inability to lie still for the duration of the exam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of 68Ga PSMA-11 PET-positive Lesions | Up to 24 months | The number of 68Ga PSMA-11 PET-positive lesions detected by staging scans will be descriptively reported. |
| Number of Overall Detected Thyroid Cancer Lesions | Up to 24 months | The number of overall thyroid cancer lesions detected by standard staging scans will be descriptively reported |
| Mean Standardized Uptake Value Maximum of Gallium-68 PSMA (SUVmax) | Up to 6 months | The mean and standard deviation for SUVmax across all lesions across all patients will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers | Up to 24 months | 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. |
| Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers | Up to 24 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) |
|---|---|
| Age, Customized 40-49 years old | 2 Participants |
| Age, Customized 50-59 years old | 2 Participants |
| Age, Customized 60-69 years old | 4 Participants |
| Age, Customized 70-79 years old | 3 Participants |
| Age, Customized 80-89 years old | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
| Years from initial diagnosis to study imaging | 3 years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: Up to 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Mean Standardized Uptake Value Maximum of Gallium-68 PSMA (SUVmax) | 8.5 Ratio | Standard Deviation 5.7 |
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.
Time frame: Up to 24 months
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Number of 68Ga PSMA-11 PET-positive Lesions | 28 lesions |
Primary
Number of Overall Detected Thyroid Cancer Lesions
The number of overall thyroid cancer lesions detected by standard staging scans will be descriptively reported
Time frame: Up to 24 months
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Number of Overall Detected Thyroid Cancer Lesions | 43 lesions |
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.
Time frame: Up to 24 months
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers | .65 proportion of participants |
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.
Time frame: Up to 24 months
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers | 1.00 proportion of participants |