Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer

Phase 3

Not yet recruiting

• Conditions: Breast Cancer Metastatic
• Interventions: Drug: 68Ga-DOTATOC

• Registration Number: NCT06611891
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-20
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Study Start: 2024-10
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer.	68Ga-DOTATOC	1. Prescreening of the patient followed for metastatic breast cancer during the routine care 2. V1 Selection: Patient's selection in the Nuclear Medicin or Oncology department 3. V2 Inclusion: The day of the 68Ga-Dotatoc PET scan in the Nuclear Medicin department 4. V3 End of study visit, the same day after the 68Ga-Dotatoc PET scan.

Primary Outcome Measures

Name	Time	Method
Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer	Baseline (during the PET examination)	Krenning Score \>2

Secondary Outcome Measures

Name	Time	Method
Distribution of SST2 receptor overexpression by 68Ga-DOTATOC PET compared to 18F-FDG PET lesions.	Baseline (during the PET examination)	Lesion-by-lesion analysis of lesion fixation intensity on 68Ga-DOTATOC PET (Krenning score (requires comparison to the liver and spleen (or kidney if not applicable) and calculated between 0 and 4) and PET quantification parameters).
Disease proportion with SST2 receptor overexpression by 68Ga-DOTATOC PET compared to known metastatic disease by 18F-FDG PET	Baseline (during the PET examination)	Disease volume per patient with overexpression of SST2 receptors in 68Ga-DOTATOC PET compared to metabolic volume in 18F-FDG PET
Expression of SST2 receptors of lesions as a function of different metastatic sites, via the Krenning score	Baseline (during the PET examination)	Krenning Score (from 0 to 4, 0 is none and 4 is greater than that of spleen, lesion with very low or no DOTATOC uptake (Score 0 or 1) are consider as a negative lesion, lesion with DOTATOC uptake ≥ 2 are consider as a positive lesion)
Expression of SST2 receptors of lesions as a function of different metastatic sites, via the PET quantification parameters.	Baseline (during the PET examination)	PET quantification parameters (SUV max and SUV mean)
Correlation between the metabolic activity of 18F-FDG PET lesions and the expression of SST2 receptors in 68Ga-DOTATOC PET per lesion and per patient.	Baseline (during the PET examination)	Comparison between 68Ga-DOTATOC PET and 18F-FDG PET (Krenning score and PET quantification parameter) per lesion and per patient.
Clinica predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient	Baseline (during the PET examination)	Clinical data prior to PET at 68Ga-DOTATOC per patient
Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient	Baseline (during the PET examination)	Biological data prior to PET at 68Ga-DOTATOC per patient
Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient	Baseline (during the PET examination)	Histological data prior to PET at 68Ga-DOTATOC per patient
Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient	Baseline (during the PET examination)	Imaging data prior to PET at 68Ga-DOTATOC per patient
Clinical predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion	Baseline (during the PET examination)	Clinical data prior to PET at 68Ga-DOTATOC per lesion
Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion	Baseline (during the PET examination)	Biological data prior to PET at 68Ga-DOTATOC per lesion
Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion	Baseline (during the PET examination)	Histological data prior to PET at 68Ga-DOTATOC per lesion
Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion	Baseline (during the PET examination)	Imaging data prior to PET at 68Ga-DOTATOC per lesion

Trial Locations

Locations (1)

CHU Grenoble Alpes; 🇫🇷 Grenoble, France