CHU Grenoble Alpes
Grenoble, 38043, France
Location status: Recruiting
Location contact
Emmanuelle JACQUET, MD, PHD
CONTACT
Emmanuelle JACQUET, MD, PHD
SUB_INVESTIGATOR
Loic DJAILEB, MD, PHD
CONTACT
Loic DJAILEB, MD, PHD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06611891
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.
Interested in participating?
Request Info18 year–99 year
Female
Interventional
Phase 3
Grenoble, 38043, France
Location status: Recruiting
Emmanuelle JACQUET, MD, PHD
CONTACT
Emmanuelle JACQUET, MD, PHD
SUB_INVESTIGATOR
Loic DJAILEB, MD, PHD
CONTACT
Loic DJAILEB, MD, PHD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Slow direct intravenous injection
Time frame: Baseline (during the PET examination)
Krenning Score >2
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: Baseline (during the PET examination)
PET quantification parameters (SUV max and SUV mean)
Time frame: 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.
Time frame: Baseline (during the PET examination)
Clinical data prior to PET at 68Ga-DOTATOC per patient
Time frame: Baseline (during the PET examination)
Biological data prior to PET at 68Ga-DOTATOC per patient
Time frame: Baseline (during the PET examination)
Histological data prior to PET at 68Ga-DOTATOC per patient
Time frame: Baseline (during the PET examination)
Imaging data prior to PET at 68Ga-DOTATOC per patient
Time frame: Baseline (during the PET examination)
Clinical data prior to PET at 68Ga-DOTATOC per lesion
Time frame: Baseline (during the PET examination)
Biological data prior to PET at 68Ga-DOTATOC per lesion
Time frame: Baseline (during the PET examination)
Histological data prior to PET at 68Ga-DOTATOC per lesion
Time frame: Baseline (during the PET examination)
Imaging data prior to PET at 68Ga-DOTATOC per lesion
Contact information is provided by the study sponsor or research team.
Marine FAURE
CONTACT
Pierre PITTET
CONTACT
University Hospital, Grenoble
Other
Acronym: DOTABREAST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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