Thyroid Gland CarcinomaPhase 2NCT03463889
Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer
A Phase 2 study testing Gallium Ga 68-labeled PSMA-11, Magnetic Resonance Imaging and Positron Emission Tomography (PET) in people with Thyroid Gland Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Gland Carcinoma
- What is being tested?
- Gallium Ga 68-labeled PSMA-11, Magnetic Resonance Imaging and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 31 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: Gallium-68 Prostate Specific Membrane Antigen (68Ga-PSMA) PET for Imaging of Thyroid Cancer: A Feasibility Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET imaging in patients with thyroid cancer.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Thyroid Gland Carcinoma
- Being tested
- Gallium Ga 68-labeled PSMA-11, Magnetic Resonance Imaging, Positron Emission Tomography (PET)
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium Ga 68-labeled PSMA-11Drug
Also called 68Ga-HBED-CC-PSMA, 68Ga-PSMA-11, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo MRI in combination with PET
Positron Emission Tomography (PET)Procedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography
Undergo PET in combination with MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start19 Mar 2018
- Primary completion30 Sep 2020
- Study completion31 Oct 2020
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid Gland CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Flavell, MD, PhD, University of California, San Francisco
- Investigators
- Robert Flavell, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463889
- Sponsor's protocol ID
- 172016
- Other IDs
- NCI-2018-00055
- Status last verified
- Jun 2021
- First submitted
- 9 Feb 2018
- Last updated
- 29 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallium-68 Prostate Specific Membrane Antigen (68Ga-PSMA) PET for Imaging of Thyroid Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03463889
- Acronym / sponsor ID
- 172016
- Conditions
- Thyroid Gland Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET imaging in patients with thyroid cancer.
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) | Experimental | Drug: Gallium Ga 68-labeled PSMA-11, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography (PET)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Gallium Ga 68-labeled PSMA-11Also: 68Ga-HBED-CC-PSMA, 68Ga-PSMA-11, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11Given IV | Drug | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo MRI in combination with PET | Procedure or surgery | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) |
| Positron Emission Tomography (PET)Also: Medical Imaging, Positron Emission Tomography, PET Scan, Positron Emission Tomography Scan, Positron-Emission TomographyUndergo PET in combination with MRI | Procedure or surgery | Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI) |
Primary outcome
Number of 68Ga PSMA-11 PET-positive Lesions
Time frame: 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
Time frame: 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)
Time frame: Up to 6 months
The mean and standard deviation for SUVmax across all lesions across all patients will be reported.
2 secondary outcomes
Sensitivity of Gallium-68 PSMA for the Detection of Thyroid Cancers
Time frame: Up to 24 months
Specificity of Gallium-68 PSMA for the Detection of Thyroid Cancers
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert Flavell, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gallium Ga 68-labeled PSMA-11, Magnetic Resonance Imaging and Positron Emission Tomography (PET) in people with Thyroid Gland Carcinoma, run by University of California, San Francisco 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 4 inclusion and 4 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 29 Jun 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of 68Ga PSMA-11 PET-positive Lesions (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2021.