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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 68Ga-DOTATOC
  Slow direct intravenous injection

Первичные конечные точки

• Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer [Срок оценки: Baseline (during the PET examination)]

Вторичные конечные точки (12)

• Distribution of SST2 receptor overexpression by 68Ga-DOTATOC PET compared to 18F-FDG PET lesions. [Срок оценки: Baseline (during the PET examination)]
• Disease proportion with SST2 receptor overexpression by 68Ga-DOTATOC PET compared to known metastatic disease by 18F-FDG PET [Срок оценки: Baseline (during the PET examination)]
• Expression of SST2 receptors of lesions as a function of different metastatic sites, via the Krenning score [Срок оценки: Baseline (during the PET examination)]
• Expression of SST2 receptors of lesions as a function of different metastatic sites, via the PET quantification parameters. [Срок оценки: 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. [Срок оценки: Baseline (during the PET examination)]
• Clinica predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient [Срок оценки: Baseline (during the PET examination)]
• Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient [Срок оценки: Baseline (during the PET examination)]
• Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient [Срок оценки: Baseline (during the PET examination)]
• Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient [Срок оценки: Baseline (during the PET examination)]
• Clinical predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion [Срок оценки: Baseline (during the PET examination)]
• Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion [Срок оценки: Baseline (during the PET examination)]
• Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion [Срок оценки: Baseline (during the PET examination)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• CHU Grenoble Alpes — Grenoble

Публикации

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• Ozelius L, Kramer PL, Moskowitz CB, Kwiatkowski DJ, Brin MF, Bressman SB, Schuback DE, Falk CT, Risch N, de Leon D, et al. Human gene for torsion dystonia located on chromosome 9q32-q34. Neuron. 1989 May;2(5):1427-34. doi: 10.1016/0896-6273(89)90188-8. PMID 2576373
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• Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Oberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTE PMID 28076709
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• Dude I, Zhang Z, Rousseau J, Hundal-Jabal N, Colpo N, Merkens H, Lin KS, Benard F. Evaluation of agonist and antagonist radioligands for somatostatin receptor imaging of breast cancer using positron emission tomography. EJNMMI Radiopharm Chem. 2017;2(1):4. doi: 10.1186/s41181-017-0023-y. Epub 2017 Apr 17. PMID 29503845
• Sollini M, Erba PA, Fraternali A, Casali M, Di Paolo ML, Froio A, Frasoldati A, Versari A. PET and PET/CT with 68gallium-labeled somatostatin analogues in Non GEP-NETs Tumors. ScientificWorldJournal. 2014 Feb 13;2014:194123. doi: 10.1155/2014/194123. eCollection 2014. PMID 24693229

Идентификаторы

NCT: NCT06611891 · 38RC21.0432

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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