NCT05478733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

July 26, 2022

Last Update Submit

June 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • patient with no oncological involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Study Officials

  • LAMBERT Aurélien, MD, MSc

    ICL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 28, 2022

Study Start

September 1, 2022

Primary Completion

December 1, 2022

Study Completion

July 1, 2023

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations