Study of Factors Associated With Significant MYoCArdian Uptake on 68Ga-DOTATOC PET Scans for Oncology (MYCADO)

Chemotherapy-related cardiovascular morbidity and mortality in cancer patients is a public health concern. Although several imaging techniques exist to prevent and monitor chemo-induced cardiotoxic effects, the lack of recommendation and consensus is a barrier to reducing cardiac adverse events in this population. PET/CT with Gallium-68 somatostatin analogues (68Ga-DOTATOC, 68Ga-DOTATATE...) is now part of the reference imaging of neuroendocrine tumors (pulmonary, gastrointestinal, pancreatic, pheochromocytoma / paraganglioma, medullary thyroid cancer...), allowing to evaluate their extension and to follow up. Their treatment, including a large arsenal of chemotherapy (etoposide, capecitabine, cisplatin, etc.), may cause cardiotoxicity, which is difficult to assess.

Study Overview

• Status: Completed
• Conditions: Oncologic Disorders

Detailed Description

Chemotherapy-related cardiovascular morbidity and mortality in cancer patients is a public health concern. Although several imaging techniques exist to prevent and monitor chemo-induced cardiotoxic effects, the lack of recommendation and consensus is a barrier to reducing cardiac adverse events in this population. PET/CT with Gallium-68-labeled somatostatin analogues (68Ga-DOTATOC, 68Ga-DOTATATE...) is now part of the reference imaging of neuroendocrine tumors (pulmonary, gastrointestinal, pancreatic, pheochromocytoma/paraganglioma, medullary thyroid cancer...), allowing to evaluate their extension and to perform follow-up . Their treatment, including a large arsenal of chemotherapy (etoposide, capecitabine, cisplatin, etc.), may cause cardiotoxicity, which is difficult to assess. However, significant cardiac area uptake has been found on some 68Ga-DOTATOC PET/CT scans in oncology. This uptake could be related either to the patient's cardiac history (inflammatory atheromatous valvular and/or coronary lesions), some studies having shown the association between the uptake of a somatostatin analogue and the presence of calcified plaques, or to a possible chemo-induced cardiotoxicity which, to our knowledge, no study has investigated. Thus, the identification of 68Ga-DOTATOC binding patterns in the cardiac area in relation to chemo-induced cardiotoxicity would have the advantage of avoiding the multiplication of examinations in the initial and follow-up work-up, thus allowing the combined evaluation of the disease and the cardiac adverse effects induced by its treatments, and thus a better control of the cardio-induced morbidity and mortality of patients with a neuroendocrine tumor.

The hypothesis of this study is that 68Ga-DOTATOC PET/CT scans with oncological indications sometimes show significant uptake in the cardiac area, which could be related to inflammatory atheromatous coronary/valvular lesions, or to a recent history of potentially cardiotoxic oncological treatments (or to diffuse somatic inflammation?)

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les Nancy cedex, France, 54511
    • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patient having performed one or more 68Ga-DOTATOC PET/CT scans for oncology indications

Description

Inclusion Criteria:

• patient having performed one or more 68Ga-DOTATOC PET/CT scans for oncology indications between 2019 and 2021 (23/01/2019 to 08/12/2021)
• patient who stayed in the nuclear medicine department between 2019 and 2021

Exclusion Criteria:

• patient with no oncological involvement

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between measurements and cardiac hyperfixation	Correlation between measurements of myocardial activity ratios and possible cardiac hyperfixation sites with blood activity and presence of cardiovascular history, and health data collected such as cardiovascular risk factors (and their number), and the existence of recent chemotherapy or radiotherapy treatment.	2 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: LAMBERT Aurélien, MD, MSc, ICL

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021PI237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No