PET Imaging in Patients With Suspected Cardiac Sarcoidosis

NCT ID: NCT03746847

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-12-01

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.

Conditions

Cardiac Sarcoidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Suspected Cardiac Sarcoidosis

patients with biopsy proven or suspected sarcoidosis (based on standard clinical imaging findings).

Gallium-68 DOTATATE

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Accelerator Applications

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Paco Bravo, MD

Assistant Professor of Radiology at the Hospital of the University of Pennsylvania

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

829715

Identifier Type: -

Identifier Source: org_study_id