Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
NCT ID: NCT06611891
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
25 participants
INTERVENTIONAL
2025-01-06
2026-10-31
Brief Summary
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This is a prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer.
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.
68Ga-DOTATOC
Slow direct intravenous injection
Interventions
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68Ga-DOTATOC
Slow direct intravenous injection
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
99 Years
FEMALE
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Loic DJAILEB
Role: PRINCIPAL_INVESTIGATOR
CHU Grenoble Alpes
Locations
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CHU Grenoble Alpes
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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; 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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Fiche info - SOMAKIT TOC 40 microgrammes, trousse pour préparation radiopharmaceutique - Base de données publique des médicaments.
111In-Pentetreotide Scintigraphy Versus 68Ga-DOTATATE PET: Impact on Krenning Scores and Effect of Tumor Burden
Other Identifiers
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38RC21.0432
Identifier Type: -
Identifier Source: org_study_id
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