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Trial Title:
Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
NCT ID:
NCT06611891
Condition:
Breast Cancer Metastatic
Conditions: Official terms:
Breast Neoplasms
Edotreotide
Conditions: Keywords:
Breast Cancer Metastatic
Somatostatin Receptor Expression
PET-SCAN
68Ga-DOTATOC
Nuclear Oncology
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
25 patients: 25 patients with breast cancer labeled on the primary lesion ER+HER2-
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-DOTATOC
Description:
Slow direct intravenous injection
Arm group label:
Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer.
Summary:
DOTABREAST: Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in
Patients Followed for Metastatic Breast Cancer
This is a prospective, monocentric, non-controlled, non-randomized, open-label,
interventional study.
Detailed description:
In women, breast cancer is the 1st largest cancer and accounted for 31% of new cancer
cases in women in 2017. With 11,913 deaths in 2015, breast cancer is the 1st largest
cancer death in women (19%) and the 3rd largest cancer death (men and women included)
after lung and colorectal cancer. At initial diagnosis at any stage, approximately 31% of
patients have regional lymph node involvement and 5 to 10% present metastatic involvement
from the outset. Progression to a metastatic form occurs in about 20% of cases. The risk
of metastatic evolution is variable depending on the histological subtype and is a major
prognostic event directly impacting overall survival. DOTATOC-68Ga PET scans allows in
vivo evaluation of SST2 somatostatin receptor expression. Its use is widely validated in
clinical practice for the assessment of extension of neuroendocrine tumors. It is also
being used to evaluate the feasibility of SST2-targeted internal radiotherapy therapy
with Litthera (177Lu-Oxodotreotide) in patients with metastatic small intestine
neuroendocrine tumours.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age over 18
- Patients with metastatic breast cancer who have completed at least one first line of
systemic therapy for metastatic breast cancer
- Patient labeled on the primary lesion ER+HER2- (20)
- Presence of metastatic liver and bone lesions identifiable with 18F-FDG PET-Scan
- Presence of at least 10 identifiable secondary lesions in 18F-FDG PET-Scan
- No therapeutic change between 18F-FDG PET-Scan and 68Ga-DOTATOC PET-Scan.
- Performing the PET scan with 68Ga-DOTATOC within a maximum of 21 days after the
18F-FDG PET-Scan
- Person affiliated to or benefiting from social security
- Person who has given written informed consent
Exclusion Criteria:
- Patients followed or with history of other active neoplastic pathology (including
neuroendocrine tumor)
- Known allergy to 68Ga-DOTATOC or its excipients
- Subject refusing to sign the consent to participate
- Minor subject
- Subject excluded from another study
- Persons referred to Articles L1121-5 to L1121-8 of the Public Health Code (CSP)
- Subject cannot be contacted in case of emergency
Gender:
Female
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Grenoble Alpes
Address:
City:
Grenoble
Zip:
38043
Country:
France
Contact:
Last name:
Loic DJAILEB, MD, PHD
Phone:
0476765455
Email:
ldjaileb@chu-grenoble.fr
Contact backup:
Last name:
Emmanuelle JACQUET, MD, PHD
Phone:
0476765451
Email:
ejacquet1@chu-grenoble.fr
Contact backup:
Last name:
Loic DJAILEB, MD, PHD
Contact backup:
Last name:
Emmanuelle JACQUET, MD, PHD
Start date:
October 2024
Completion date:
October 2026
Lead sponsor:
Agency:
University Hospital, Grenoble
Agency class:
Other
Source:
University Hospital, Grenoble
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06611891
https://base-donnees-publique.medicaments.gouv.fr/extrait.php?specid=65028549
http://www.google.com/search?client=firefox-b-1-d&q=111In-Pentetreotide+Scintigraphy+Versus+68Ga-
