Cardiac SarcoidosisPhase 4NCT03549598
d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
A Phase 4 study testing 68Ga-DOTATATE PET/CT, 18FDG PET/CT scan and 13NH3 PET/CT scan in people with Cardiac Sarcoidosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sarcoidosis
- What is being tested?
- 68Ga-DOTATATE PET/CT, 18FDG PET/CT scan and 13NH3 PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 2 Oct 2019
- Phase
- Phase 4
- 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
- 18 years of age or older
- Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)
Who cannot join
- Pregnant
- Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.
Read the detailed description
Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.
- Conditions
- Cardiac Sarcoidosis
- Being tested
- 68Ga-DOTATATE PET/CT, 18FDG PET/CT scan, 13NH3 PET/CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATATE PET/CTDrug
5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.
18FDG PET/CT scanDrug
This scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.
13NH3 PET/CT scanDrug
This scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTATATE PET/CT | Experimental | 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject Receives: Drug: 68Ga-DOTATATE PET/CT; Drug: 18FDG PET/CT scan; Drug: 13NH3 PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of abnormal myocardial increased focal uptake
Measured: 3 days
18FDG Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
Measured: 2 days
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
Measured: 2 days
Secondary outcomes (2)
Physician Confidence in Study Interpretation
A Physician survey will be conducted for those cardiac imagers assessing both the DOTATATE and FDG studies to determine their confidence level in interpreting the studies and if one study was easier to interpret than the other
Measured: 2 days
Subject Satisfaction
A patient survey will be conducted after each subject has undergone both the DOTATE and the FDG scans. Patient satisfaction will be measured by the question, "Which study did you prefer?" Subject to circle one of the following: 18FDG, 68Ga-DOTATATE or Equal
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start20 Jul 2018
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
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 Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John P. Bois, M.D., Mayo Clinic
- Investigators
- John P Bois, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549598
- Sponsor's protocol ID
- 18-000393
- Status last verified
- Sep 2020
- First submitted
- 25 May 2018
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT03549598
- Acronym / sponsor ID
- 18-000393
- Conditions
- Cardiac Sarcoidosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.
Detailed description
Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTATATE PET/CT | Experimental | Drug: 68Ga-DOTATATE PET/CT, Drug: 18FDG PET/CT scan, Drug: 13NH3 PET/CT scan68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)
Key exclusion criteria (2 listed)
- Pregnant
- Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan
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 |
|---|---|---|
| 68Ga-DOTATATE PET/CT5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route. | Drug | 68Ga-DOTATATE PET/CT |
| 18FDG PET/CT scanThis scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol. | Drug | 68Ga-DOTATATE PET/CT |
| 13NH3 PET/CT scanThis scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol. | Drug | 68Ga-DOTATATE PET/CT |
Primary outcome
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
Time frame: 3 days
The number of subjects with areas of abnormal myocardial increased focal uptake
18FDG Uptake With Cardia Sarcoidosis (CS)
Time frame: 2 days
The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
Time frame: 2 days
The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
2 secondary outcomes
Physician Confidence in Study Interpretation
Time frame: 2 days
Subject Satisfaction
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
John P Bois principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 68Ga-DOTATATE PET/CT, 18FDG PET/CT scan and 13NH3 PET/CT scan in people with Cardiac Sarcoidosis, run by Mayo Clinic 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 2 inclusion and 2 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 20 Oct 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 20 Oct 2020). 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?
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS) (time frame: 3 days). 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 20 Oct 2020.