Neuroendocrine TumorsNCT05680675
Dual-Tracer Theranostic PET
A study testing Single-Tracer FDG PET/CT Exam, Single-Tracer Cu64-DOTATATE PET/CT Exam and Single-Tracer Ga68-DOTATATE PET/CT Exam in people with Neuroendocrine Tumors and Prostate Cancer, run by University of Utah at 1 site in United States.
Trial summary
This study is designed to obtain positron emission tomography with x-ray computed tomography (PET/CT) imaging data with each tracer pair, providing the imaging data needed to develop new simultaneous dual-tracer imaging techniques and processing algorithms for these tracer pairs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Prostate Cancer
- What is being tested?
- Single-Tracer FDG PET/CT Exam, Single-Tracer Cu64-DOTATATE PET/CT Exam and Single-Tracer Ga68-DOTATATE PET/CT Exam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to 4 Jun 2024
- Phase
- Interventional
- 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
- adults aged 18 years or greater.
- willing and able to sign a written informed consent and HIPAA authorization in accordance with local and institutional guidelines.
- presence of at least 1 measurable lesion ≥ 1 cm in size.
- willing to have their clinical records reviewed for at least 24 months after enrollment.
- willing to lie flat on their back in the PET/CT scanner for up to one hour to allow for the imaging data to be obtained.
- willing to undergo two separate PET/CT exams on different days within 2 weeks of each other.
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- female participants who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans. The serum pregnancy test must be performed within 48 hours prior to research PET imaging. A negative test will be necessary for such patients to undergo research PET imaging. This only applies to Arms 1 and 2, since only males will be included in Arm 3 (only males can get prostate cancer).
- Arms 1 and 2 only: known or suspected somatostatin receptor-positive neuroendocrine tumor (NET) who could be considered for clinical use of DOTATATE PET/CT imaging under the approved indications for use of this radiopharmaceutical according to published appropriate use criteria. These indications include initial staging after the histologic diagnosis of NET, evaluation of an unknown primary; evaluation of a mass suggestive of NET not amenable to endoscopic or percutaneous biopsy, staging of NET before planned surgery, monitoring of NET seen predominantly on somatostatin receptor (SSTR) PET, evaluation of patients with biochemical evidence and symptoms of a NET, evaluation of patients with biochemical evidence of a NET without evidence on conventional imaging or a prior histologic diagnosis, restaging at time of clinical or laboratory progression without progression on conventional imaging, and new indeterminate lesion on conventional imaging with unclear progression.
- Arm 3 Only: known or suspected prostate cancer who could be considered for clinical use of PSMA PET/CT imaging under the approved indications for use of this radiopharmaceutical, including patients with suspected metastasis and patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Who cannot join
- received somatostatin receptor targeted therapy at any time prior to enrollment will be excluded from the study Arms involving DOTATATE (Arms 1-2).
- known intolerance or hypersensitivity to any somatostatin analogs will be excluded from the study Arms involving DOTATATE (Arms 1-2).
- participated in any therapeutic clinical study or received any investigational agent within the last 30 days.
- known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals
- require monitored anesthesia for PET/CT scanning.
- too claustrophobic to undergo PET/CT scanning.
- exceed the 450 lb. weight limit of the PET/CT scanner.
- pregnant or currently breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
This study is designed to obtain positron emission tomography with x-ray computed tomography (PET/CT) imaging data with each tracer pair, providing the imaging data needed to develop new simultaneous dual-tracer imaging techniques and processing algorithms for these tracer pairs.
- Conditions
- Neuroendocrine Tumors, Prostate Cancer
- Being tested
- Single-Tracer FDG PET/CT Exam, Single-Tracer Cu64-DOTATATE PET/CT Exam, Single-Tracer Ga68-DOTATATE PET/CT Exam, Single-Tracer PSMA PET/CT Exam
- Keywords
- somatostatin receptor-positive
- Medical subject headings
- Neuroendocrine Tumors, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Tracer FDG PET/CT ExamDiagnostic test
The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer Cu64-DOTATATE PET/CT ExamDiagnostic test
The PET technologist will administer with approximately 4 mCi Cu64-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer Ga68-DOTATATE PET/CT ExamDiagnostic test
The PET technologist will administer with with approximately 5 mCi Ga68-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer PSMA PET/CT ExamDiagnostic test
The PET technologist will administer with with approximately 7 mCi Ga68-PSMA-11 intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT exam + Single-Tracer Cu64-DOTATATE PET/CT Receives: Diagnostic Test: Single-Tracer FDG PET/CT Exam; Diagnostic Test: Single-Tracer Cu64-DOTATATE PET/CT Exam |
| Arm 2 | Experimental | Single-Tracer FDG PET/CT exam + Single-Tracer Ga68-DOTATATE PET/CT exam Receives: Diagnostic Test: Single-Tracer FDG PET/CT Exam; Diagnostic Test: Single-Tracer Ga68-DOTATATE PET/CT Exam |
| Arm 3 | Experimental | Single-Tracer FDG PET/CT exam + Single-Tracer PSMA (prostate-specific membrane antigen) PET/CT exam Receives: Diagnostic Test: Single-Tracer FDG PET/CT Exam; Diagnostic Test: Single-Tracer PSMA PET/CT Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm
To obtain PET/CT imaging data suitable for developing new simultaneous dual-tracer PET techniques and processing algorithms for dual-tracer imaging of Fluorine-18 fluorodeoxyglucose (FDG) + Cu64-dodecane tetraacetic acid (DOTA) tyrosine-3-octreotate (TATE) (DOTATATE), FDG + Ga68-DOTATATE, and FDG + Ga68-prostate-specific membrane antigen (PSMA)-11 PET/CT
Measured: PET/CT exams were obtained on two separate days within a two week span.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start8 Dec 2022
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
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 Neuroendocrine TumorsStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- MultiFunctional Imaging LLC, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey A Yap, PhD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680675
- Sponsor's protocol ID
- HCI158172
- Other IDs
- 2R44CA257522
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2022
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Tracer Theranostic PET
- ClinicalTrials.gov ID
- NCT05680675
- Acronym / sponsor ID
- HCI158172
- Conditions
- Neuroendocrine Tumors, Prostate Cancer
- Keywords
- somatostatin receptor-positive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- MultiFunctional Imaging LLC, National Cancer Institute (NCI)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to obtain positron emission tomography with x-ray computed tomography (PET/CT) imaging data with each tracer pair, providing the imaging data needed to develop new simultaneous dual-tracer imaging techniques and processing algorithms for these tracer pairs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Diagnostic Test: Single-Tracer FDG PET/CT Exam, Diagnostic Test: Single-Tracer Cu64-DOTATATE PET/CT ExamSingle-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT exam + Single-Tracer Cu64-DOTATATE PET/CT |
| Arm 2 | Experimental | Diagnostic Test: Single-Tracer FDG PET/CT Exam, Diagnostic Test: Single-Tracer Ga68-DOTATATE PET/CT ExamSingle-Tracer FDG PET/CT exam + Single-Tracer Ga68-DOTATATE PET/CT exam |
| Arm 3 | Experimental | Diagnostic Test: Single-Tracer FDG PET/CT Exam, Diagnostic Test: Single-Tracer PSMA PET/CT ExamSingle-Tracer FDG PET/CT exam + Single-Tracer PSMA (prostate-specific membrane antigen) PET/CT exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- adults aged 18 years or greater.
- willing and able to sign a written informed consent and HIPAA authorization in accordance with local and institutional guidelines.
- presence of at least 1 measurable lesion ≥ 1 cm in size.
- willing to have their clinical records reviewed for at least 24 months after enrollment.
- willing to lie flat on their back in the PET/CT scanner for up to one hour to allow for the imaging data to be obtained.
Key exclusion criteria (8 listed)
- received somatostatin receptor targeted therapy at any time prior to enrollment will be excluded from the study Arms involving DOTATATE (Arms 1-2).
- known intolerance or hypersensitivity to any somatostatin analogs will be excluded from the study Arms involving DOTATATE (Arms 1-2).
- participated in any therapeutic clinical study or received any investigational agent within the last 30 days.
- known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals
- require monitored anesthesia for PET/CT scanning.
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 |
|---|---|---|
| Single-Tracer FDG PET/CT ExamThe PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images. | Diagnostic test | Arm 1, Arm 2, Arm 3 |
| Single-Tracer Cu64-DOTATATE PET/CT ExamThe PET technologist will administer with approximately 4 mCi Cu64-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images. | Diagnostic test | Arm 1 |
| Single-Tracer Ga68-DOTATATE PET/CT ExamThe PET technologist will administer with with approximately 5 mCi Ga68-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images. | Diagnostic test | Arm 2 |
| Single-Tracer PSMA PET/CT ExamThe PET technologist will administer with with approximately 7 mCi Ga68-PSMA-11 intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images. | Diagnostic test | Arm 3 |
Primary outcome
Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm
Time frame: PET/CT exams were obtained on two separate days within a two week span.
To obtain PET/CT imaging data suitable for developing new simultaneous dual-tracer PET techniques and processing algorithms for dual-tracer imaging of Fluorine-18 fluorodeoxyglucose (FDG) + Cu64-dodecane tetraacetic acid (DOTA) tyrosine-3-octreotate (TATE) (DOTATATE), FDG + Ga68-DOTATATE, and FDG + Ga68-prostate-specific membrane antigen (PSMA)-11 PET/CT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey A Yap, PhD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Tracer FDG PET/CT Exam, Single-Tracer Cu64-DOTATATE PET/CT Exam and Single-Tracer Ga68-DOTATATE PET/CT Exam in people with Neuroendocrine Tumors and Prostate Cancer, run by University of Utah 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 6 Feb 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). 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?
Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm (time frame: PET/CT exams were obtained on two separate days within a two week span.). 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 6 Feb 2025.