PET Imaging in Patients With Suspected Cardiac Sarcoidosis

NCT03746847 | Completed FDA Drug

• 1 other identifier: 829715
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Dotatate SUVmax activity in the heart

  The standardized uptake value (SUV) is a nuclear medicine unit commonly used to distinguish between "normal" and "abnormal" levels of tissue uptake.

  3 years

Secondary Outcomes (1)

• Change in Dotatate SUVmax activity in the heart on follow-up PET/CT scan compared to baseline

  3 years

Study Arms (1)

Patients with Suspected Cardiac Sarcoidosis

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

Drug: Gallium-68 DOTATATE

Interventions

Gallium-68 DOTATATE 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.

Patients with Suspected Cardiac Sarcoidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Suspected Cardiac Sarcoidosis

You may qualify if:

• Participants will be ≥ 18 years of age
• History of biopsy-proven sarcoidosis OR suspected sarcoidosis based on standard clinical imaging (e.g. FDG PET/CT, MRI) without biopsy confirmation
• 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 fusion
• Any cardiac arrhythmia
• Chest pain, dyspnea or syncope without clear etiology
• FDG PET/CT scan demonstrating abnormal myocardial FDG uptake
• 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

You may not qualify if:

• 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.
• History of neuroendocrine tumors
• Currently taking the medication Octreotide
• Currently on total parenteral nutrition (TPN)
• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Advanced Accelerator Applications: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology at the Hospital of the University of Pennsylvania

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 20, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

US (1)