CancerNCT03081767
Standard PET/CT vs. Digital PET/CT
A study testing Digital PET/CT scan in people with Cancer, run by Stanford University at 1 site in United States.
Trial summary
The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Digital PET/CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 1 Apr 2021
- 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
- Patient is ≥ 18 years old at the time of the scan
- Patient provides written informed consent
- Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT
- Patient is capable of complying with study procedures
- Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)
Who cannot join
- Patient is pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Standard PET/CT vs. Digital PET/CT
The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.
Read the detailed description
There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.
- Conditions
- Cancer
- Being tested
- Digital PET/CT scan
- Keywords
- PET/CT, digital PET/CT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital PET/CT scanDiagnostic test
The Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing digital PET/CT | Other | Single arm prospective study of paired imaging studies. Patients who are referred to Nuclear Medicine and are scheduled to undergo imaging on the standard PET/CT will also have imaging performed on the digital PET/CT. Receives: Diagnostic Test: Digital PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Image Quality
Diagnostic image quality will be determined using a 5-point Likert Scale that reads:
5 - Diagnostic: Excellent diagnostic image quality;
4 - Diagnostic: Good diagnostic image quality;
3 - Diagnostic: Acceptable diagnostic image quality;
2 - Sub-optimal diagnostic: image quality with limited additional clinical information;
1 - Non-diagnostic: non-diagnostic image quality
Measured: an expected average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start29 Mar 2017
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081767
- Sponsor's protocol ID
- IRB Protocol: 39329
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2017
- Last updated
- 12 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Duan H, Baratto L, Hatami N, Liang T, Mari Aparici C, Davidzon GA, Iagaru A. 68Ga-PSMA11 PET/CT for biochemically recurrent prostate cancer: Influence of dual-time and PMT- vs SiPM-based detectors. Transl Oncol. 2022 Jan;15(1):101293. doi: 10.1016/j.tranon.2021.101293. Epub 2021 Nov 22.
PubMed 34823095Baratto L, Toriihara A, Hatami N, Aparici CM, Davidzon G, Levin CS, Iagaru A. Results of a Prospective Trial to Compare 68Ga-DOTA-TATE with SiPM-Based PET/CT vs. Conventional PET/CT in Patients with Neuroendocrine Tumors. Diagnostics (Basel). 2021 May 30;11(6):992. doi: 10.3390/diagnostics11060992.
PubMed 34070751
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard PET/CT vs. Digital PET/CT
- ClinicalTrials.gov ID
- NCT03081767
- Acronym / sponsor ID
- IRB Protocol: 39329
- Conditions
- Cancer
- Keywords
- PET/CT, digital PET/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Posted 12 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.
Detailed description
There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing digital PET/CT | Other | Diagnostic Test: Digital PET/CT scanSingle arm prospective study of paired imaging studies. Patients who are referred to Nuclear Medicine and are scheduled to undergo imaging on the standard PET/CT will also have imaging performed on the digital PET/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is ≥ 18 years old at the time of the scan
- Patient provides written informed consent
- Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT
- Patient is capable of complying with study procedures
- Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)
Key exclusion criteria (1 listed)
- Patient is pregnant or nursing
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 |
|---|---|---|
| Digital PET/CT scanThe Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner. | Diagnostic test | Patients undergoing digital PET/CT |
Primary outcome
Diagnostic Image Quality
Time frame: an expected average of 3 hours
Diagnostic image quality will be determined using a 5-point Likert Scale that reads: 5 - Diagnostic: Excellent diagnostic image quality; 4 - Diagnostic: Good diagnostic image quality; 3 - Diagnostic: Acceptable diagnostic image quality; 2 - Sub-optimal diagnostic: image quality with limited additional clinical information; 1 - Non-diagnostic: non-diagnostic image quality
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34823095Duan H, Baratto L, Hatami N, Liang T, Mari Aparici C, Davidzon GA, Iagaru A. 68Ga-PSMA11 PET/CT for biochemically recurrent prostate cancer: Influence of dual-time and PMT- vs SiPM-based detectors. Transl Oncol. 2022 Jan;15(1):101293. doi: 10.1016/j.tranon.2021.101293. Epub 2021 Nov 22.
- Results publication: PubMed 34070751Baratto L, Toriihara A, Hatami N, Aparici CM, Davidzon G, Levin CS, Iagaru A. Results of a Prospective Trial to Compare 68Ga-DOTA-TATE with SiPM-Based PET/CT vs. Conventional PET/CT in Patients with Neuroendocrine Tumors. Diagnostics (Basel). 2021 May 30;11(6):992. doi: 10.3390/diagnostics11060992.
- 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.
Andrei Iagaru, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital PET/CT scan in people with Cancer, run by Stanford University 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 5 inclusion and 1 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 12 Apr 2022. 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 12 Apr 2022). 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?
Diagnostic Image Quality (time frame: an expected average of 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081767, which also lists 2 linked publications.
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 12 Apr 2022.