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.
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 Lutathera (177Lu-Oxodotreotide) in patients with metastatic small intestine neuroendocrine tumours.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
Slow direct intravenous injection
CHU Grenoble Alpes
Grenoble, France
RECRUITINGPresence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer
Krenning Score \>2
Time frame: Baseline (during the PET examination)
Distribution of SST2 receptor overexpression by 68Ga-DOTATOC PET compared to 18F-FDG PET lesions.
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).
Time frame: Baseline (during the PET examination)
Disease proportion with SST2 receptor overexpression by 68Ga-DOTATOC PET compared to known metastatic disease by 18F-FDG PET
Disease volume per patient with overexpression of SST2 receptors in 68Ga-DOTATOC PET compared to metabolic volume in 18F-FDG PET
Time frame: Baseline (during the PET examination)
Expression of SST2 receptors of lesions as a function of different metastatic sites, via the Krenning score
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)
Time frame: Baseline (during the PET examination)
Expression of SST2 receptors of lesions as a function of different metastatic sites, via the PET quantification parameters.
PET quantification parameters (SUV max and SUV mean)
Time frame: Baseline (during the PET examination)
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.
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Comparison between 68Ga-DOTATOC PET and 18F-FDG PET (Krenning score and PET quantification parameter) per lesion and per patient.
Time frame: Baseline (during the PET examination)
Clinica predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
Clinical data prior to PET at 68Ga-DOTATOC per patient
Time frame: Baseline (during the PET examination)
Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
Biological data prior to PET at 68Ga-DOTATOC per patient
Time frame: Baseline (during the PET examination)
Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
Histological data prior to PET at 68Ga-DOTATOC per patient
Time frame: Baseline (during the PET examination)
Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
Imaging data prior to PET at 68Ga-DOTATOC per patient
Time frame: Baseline (during the PET examination)
Clinical predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
Clinical data prior to PET at 68Ga-DOTATOC per lesion
Time frame: Baseline (during the PET examination)
Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
Biological data prior to PET at 68Ga-DOTATOC per lesion
Time frame: Baseline (during the PET examination)
Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
Histological data prior to PET at 68Ga-DOTATOC per lesion
Time frame: Baseline (during the PET examination)
Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
Imaging data prior to PET at 68Ga-DOTATOC per lesion
Time frame: Baseline (during the PET examination)