Oncologic DisordersMYCADONCT05478733
Study of Factors Associated With Significant MYoCArdian Uptake on 68Ga-DOTATOC PET Scans for Oncology
An observational study of Oncologic Disorders, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Disorders
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient having performed one or more 68Ga-DOTATOC PET/CT scans for oncology indications
Who may be able to join
- 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
Who cannot join
- patient with no oncological involvement
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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?)
- Conditions
- Oncologic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DisordersStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Yves MARIE, Central Hospital, Nancy, France
- Investigators
- LAMBERT Aurélien, MD, MSc, Principal investigator, ICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478733
- Sponsor's protocol ID
- 2021PI237
- Acronym
- MYCADO
- Status last verified
- Jun 2024
- First submitted
- 26 Jul 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Factors Associated With Significant MYoCArdian Uptake on 68Ga-DOTATOC PET Scans for Oncology
- ClinicalTrials.gov ID
- NCT05478733
- Acronym / sponsor ID
- MYCADO / 2021PI237
- Conditions
- Oncologic Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient having performed one or more 68Ga-DOTATOC PET/CT scans for oncology indications
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- patient with no oncological involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between measurements and cardiac hyperfixation
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Related trials for Oncologic Disorders
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
RecruitingObservational study
Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity
Breast Cancer
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAMBERT Aurélien, MD, MSc principal investigator
ICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncologic Disorders, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between measurements and cardiac hyperfixation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.