SarcoidosisNCT02546388
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
A study testing Indium-111 Pentreotide and Gallium-68 DOTATATE in people with Sarcoidosis, run by Marcelo F. Di Carli, MD, FACC at 1 site in United States.
Trial summary
The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better. OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Indium-111 Pentreotide and Gallium-68 DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Aug 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 or older
- Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy
- Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope
- PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium.
Who cannot join
- Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart.
- Patients with history of neuroendocrine tumors (specially insulinomas)
- Patients taking the medication Octreotide
- Patients on total parenteral nutrition (TPN)
- Women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better.
OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.
- Conditions
- Sarcoidosis
- Being tested
- Indium-111 Pentreotide, Gallium-68 DOTATATE
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indium-111 PentreotideDrug
Also called OctreoScan
Gallium-68 DOTATATEDrug
| Study group | Role | What they receive |
|---|---|---|
| Indium-111 Pentreotide (OctreoScan) | Experimental | Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection. Receives: Drug: Indium-111 Pentreotide |
| Gallium-68 DOTATATE | Experimental | Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging 1 hour after injection for DOTATATE. Receives: Drug: Gallium-68 DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Characterized by Abnormal or Negative Uptake
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Measured: 1 hour
Secondary outcomes (1)
Effect of Treatment
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2018
- Study completionAug 2018
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 SarcoidosisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcelo F. Di Carli, MD, FACC
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546388
- Sponsor's protocol ID
- 2015P001421
- Status last verified
- Apr 2020
- First submitted
- 9 Sep 2015
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT02546388
- Acronym / sponsor ID
- 2015P001421
- Conditions
- Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Marcelo F. Di Carli, MD, FACCUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Oct 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better.
OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indium-111 Pentreotide (OctreoScan) | Experimental | Drug: Indium-111 PentreotidePatients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection. |
| Gallium-68 DOTATATE | Experimental | Drug: Gallium-68 DOTATATEPatients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging 1 hour after injection for DOTATATE. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 18 or older
- Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy
- Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope
- PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium.
Key exclusion criteria (5 listed)
- Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart.
- Patients with history of neuroendocrine tumors (specially insulinomas)
- Patients taking the medication Octreotide
- Patients on total parenteral nutrition (TPN)
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| Indium-111 PentreotideAlso: OctreoScan | Drug | Indium-111 Pentreotide (OctreoScan) |
| Gallium-68 DOTATATE | Drug | Gallium-68 DOTATATE |
Primary outcome
Number of Participants Characterized by Abnormal or Negative Uptake
Time frame: 1 hour
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
1 secondary outcome
Effect of Treatment
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indium-111 Pentreotide and Gallium-68 DOTATATE in people with Sarcoidosis, run by Marcelo F. Di Carli, MD, FACC 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 5 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 9 Apr 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 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?
Number of Participants Characterized by Abnormal or Negative Uptake (time frame: 1 hour). 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 9 Apr 2020.