Evaluating Somatostatin Receptor Expression in Metastatic Breast Cancer Patients
Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
PHASE3 · University Hospital, Grenoble · NCT06611891
This study is testing if a special type of PET scan can help women with metastatic breast cancer see how their cancer is spreading and what treatment options might work best for them.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University Hospital, Grenoble (other) |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT06611891 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate somatostatin receptor expression using PET scans with 68Ga-DOTATOC in women diagnosed with metastatic breast cancer. It is a prospective, monocentric, non-controlled, and open-label study that includes patients who have undergone at least one line of systemic therapy. The study focuses on assessing the feasibility of using 68Ga-DOTATOC PET scans to identify and evaluate metastatic lesions in patients with specific receptor profiles. The goal is to improve understanding of metastatic breast cancer progression and treatment options.
Who should consider this trial
Good fit: Ideal candidates are women over 18 with metastatic breast cancer who have completed at least one line of systemic therapy and have identifiable metastatic lesions.
Not a fit: Patients with other active neoplastic diseases or those who are minors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to identify and target metastatic breast cancer lesions, potentially leading to improved treatment outcomes.
How similar studies have performed: While the use of 68Ga-DOTATOC PET scans has been validated in neuroendocrine tumors, its application in metastatic breast cancer is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Grenoble
- CHU Grenoble Alpes — Grenoble, France (RECRUITING)
Study contacts
- Principal investigator: Loic DJAILEB — CHU Grenoble Alpes
- Study coordinator: Marine FAURE
- Email: MFaure6@chu-grenoble.fr
- Phone: 0476766872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Metastatic, Somatostatin Receptor Expression, PET-SCAN, 68Ga-DOTATOC, Nuclear Oncology, 177-Lu-Oxodotreotide, DOTATOC