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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATOC | Drug | Slow direct intravenous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer | Krenning Score >2 | Baseline (during the PET examination) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (during the PET examination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marine FAURE | Contact | 0476766872 | MFaure6@chu-grenoble.fr | |
| Pierre PITTET | Contact | 0476766872 | ppittet@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Loic DJAILEB | CHU Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble Alpes | Recruiting | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28107508 | Background | Dalm SU, Schrijver WA, Sieuwerts AM, Look MP, Ziel-van der Made AC, de Weerd V, Martens JW, van Diest PJ, de Jong M, van Deurzen CH. Prospects of Targeting the Gastrin Releasing Peptide Receptor and Somatostatin Receptor 2 for Nuclear Imaging and Therapy in Metastatic Breast Cancer. PLoS One. 2017 Jan 20;12(1):e0170536. doi: 10.1371/journal.pone.0170536. eCollection 2017. | |
| 29025982 |
| Label | URL |
|---|---|
| Fiche info - SOMAKIT TOC 40 microgrammes, trousse pour préparation radiopharmaceutique - Base de données publique des médicaments. | View source |
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| ID | Term |
|---|---|
| C499142 | Ga(III)-DOTATOC |
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25 patients: 25 patients with breast cancer labeled on the primary lesion ER+HER2-
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| 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 | 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) | 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) | 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. | Comparison between 68Ga-DOTATOC PET and 18F-FDG PET (Krenning score and PET quantification parameter) per lesion and per patient. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline (during the PET examination) |
| Background |
| Hope TA, Bergsland EK, Bozkurt MF, Graham M, Heaney AP, Herrmann K, Howe JR, Kulke MH, Kunz PL, Mailman J, May L, Metz DC, Millo C, O'Dorisio S, Reidy-Lagunes DL, Soulen MC, Strosberg JR. Appropriate Use Criteria for Somatostatin Receptor PET Imaging in Neuroendocrine Tumors. J Nucl Med. 2018 Jan;59(1):66-74. doi: 10.2967/jnumed.117.202275. Epub 2017 Oct 12. No abstract available. |
| 2576373 | Background | 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. |
| 20596866 | Background | Virgolini I, Ambrosini V, Bomanji JB, Baum RP, Fanti S, Gabriel M, Papathanasiou ND, Pepe G, Oyen W, De Cristoforo C, Chiti A. Procedure guidelines for PET/CT tumour imaging with 68Ga-DOTA-conjugated peptides: 68Ga-DOTA-TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE. Eur J Nucl Med Mol Imaging. 2010 Oct;37(10):2004-10. doi: 10.1007/s00259-010-1512-3. |
| 28076709 | Result | 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; NETTER-1 Trial Investigators. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427. |
| 25075022 | Result | Frati A, Rouzier R, Lesieur B, Werkoff G, Antoine M, Rodenas A, Darai E, Chereau E. Expression of somatostatin type-2 and -4 receptor and correlation with histological type in breast cancer. Anticancer Res. 2014 Aug;34(8):3997-4003. |
| 29503845 | Result | 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. |
| 24693229 | Result | 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. |
| 28450563 | Result | Dalm SU, Haeck J, Doeswijk GN, de Blois E, de Jong M, van Deurzen CHM. SSTR-Mediated Imaging in Breast Cancer: Is There a Role for Radiolabeled Somatostatin Receptor Antagonists? J Nucl Med. 2017 Oct;58(10):1609-1614. doi: 10.2967/jnumed.116.189035. Epub 2017 Apr 27. |
| 111In-Pentetreotide Scintigraphy Versus 68Ga-DOTATATE PET: Impact on Krenning Scores and Effect of Tumor Burden | View source |