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PET Imaging in Patients With Suspected Cardiac Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03746847
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
Advanced Accelerator Applications
Information provided by (Responsible Party):
Paco Bravo, MD, University of Pennsylvania

Study Description
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Brief Summary:
Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors. The study will see how the tracer is taken up in your heart before and after treatment using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Investigators are doing this research study to find out if DOTATATE can help doctors diagnose people with cardiac (heart) sarcoidosis better as well as serve as a follow-up monitoring tool for a response to therapy.

Condition or disease Intervention/treatment
Cardiac Sarcoidosis Drug: Gallium-68 DOTATATE

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 5, 2021
Estimated Study Completion Date : December 1, 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with Suspected Cardiac Sarcoidosis
patients with biopsy proven or suspected sarcoidosis (based on standard clinical imaging findings).
 Drug: Gallium-68 DOTATATE
Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.


Outcome Measures
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Primary Outcome Measures :
  1. Dotatate SUVmax activity in the heart [ Time Frame: 3 years ]
    The standardized uptake value (SUV) is a nuclear medicine unit commonly used to distinguish between "normal" and "abnormal" levels of tissue uptake.


Secondary Outcome Measures :
  1. Change in Dotatate SUVmax activity in the heart on follow-up PET/CT scan compared to baseline [ Time Frame: 3 years ]
    Dotatate activity (in SUVmax units) in the heart will be measured at baseline and then again at least 3 months after immunotherapy initiation in subjects with suspected cardiac sarcoidosis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Suspected Cardiac Sarcoidosis
Criteria

Inclusion Criteria:

  1. Participants will be ≥ 18 years of age
  2. History of biopsy-proven sarcoidosis OR suspected sarcoidosis based on standard clinical imaging (e.g. FDG PET/CT, MRI) without biopsy confirmation

  3. Clinical suspicion of cardiac involvement defined as the presence of any of the following:

    1. High degree A-V nodal block
    2. Complete bundle branch block
    3. Reduced left or right ventricular systolic fusion
    4. Any cardiac arrhythmia
    5. Chest pain, dyspnea or syncope without clear etiology
  4. FDG PET/CT scan demonstrating abnormal myocardial FDG uptake
  5. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion Criteria:

  1. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
  2. History of neuroendocrine tumors
  3. Currently taking the medication Octreotide
  4. Currently on total parenteral nutrition (TPN)
  5. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  6. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746847


Contacts
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Contact: Zeinab Helili 215-746-3230 zeinab.helili@uphs.upenn.edu
Contact: Erin Schubert 215-573-6569 Erin.Schubert@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Zeinab Helili    215-746-3230    zeinab.helili@uphs.upenn.edu   
Contact: Erin Schubert    215-573-6569    Erin.Schubert@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Advanced Accelerator Applications
More Information
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Responsible Party: Paco Bravo, MD, Assistant Professor of Radiology at the Hospital of the University of Pennsylvania, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03746847    
Other Study ID Numbers: 829715
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases