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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05478733
Collaborator
(none)
210
7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    210 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Study of Factors Associated With Significant MYoCArdian Uptake on 68Ga-DOTATOC PET Scans for Oncology
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between measurements and cardiac hyperfixation [2 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05478733
    Other Study ID Numbers:
    • 2021PI237
    First Posted:
    Jul 28, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 28, 2022