Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05478733 |
| Other study ID # |
2021PI237 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
June 2024 |
| Source |
Central Hospital, Nancy, France |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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?)
