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Completed

NCT Number: NCT03549598

d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.

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Key information

Conditions

Cardiac Sarcoidosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

Exclusion criteria

  • Pregnant
  • Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan

Treatment and study plan

68Ga-DOTATATE PET/CT

Drug

5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.

18FDG PET/CT scan

Drug

This scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.

13NH3 PET/CT scan

Drug

This scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.

Primary outcomes

  1. 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)

    Time frame: 3 days

    The number of subjects with areas of abnormal myocardial increased focal uptake

  2. 18FDG Uptake With Cardia Sarcoidosis (CS)

    Time frame: 2 days

    The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan

  3. 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)

    Time frame: 2 days

    The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan

Secondary outcomes

  1. Physician Confidence in Study Interpretation

    Time frame: 2 days

    A Physician survey will be conducted for those cardiac imagers assessing both the DOTATATE and FDG studies to determine their confidence level in interpreting the studies and if one study was easier to interpret than the other

  2. Subject Satisfaction

    Time frame: 2 days

    A patient survey will be conducted after each subject has undergone both the DOTATE and the FDG scans. Patient satisfaction will be measured by the question, "Which study did you prefer?" Subject to circle one of the following: 18FDG, 68Ga-DOTATATE or Equal

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Oct 20, 2020

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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