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OpenTrials
Completed

NCT Number: NCT03746847

PET Imaging in Patients With Suspected Cardiac Sarcoidosis

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.

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Key information

Conditions

Cardiac Sarcoidosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Advanced Accelerator Applications

Registry information

Official study title

Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2018
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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