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

NCT06611891 | Recruiting Phase 3

• 1 other identifier: 38RC21.0432
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Metastatic

Keywords

Breast Cancer Metastatic; Somatostatin Receptor Expression; PET-SCAN; 68Ga-DOTATOC; Nuclear Oncology; 177-Lu-Oxodotreotide; DOTATOC

Outcome Measures

Primary Outcomes (1)

• Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer

  Krenning Score \>2

  Baseline (during the PET examination)

Secondary Outcomes (13)

• Distribution of SST2 receptor overexpression by 68Ga-DOTATOC PET compared to 18F-FDG PET lesions.

  Baseline (during the PET examination)

• Disease proportion with SST2 receptor overexpression by 68Ga-DOTATOC PET compared to known metastatic disease by 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

  Baseline (during the PET examination)

• Expression of SST2 receptors of lesions as a function of different metastatic sites, via the PET quantification parameters.

  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.

  Baseline (during the PET examination)

Study Arms (1)

Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer.

EXPERIMENTAL

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.

Drug: 68Ga-DOTATOC

Interventions

68Ga-DOTATOC DRUG

Slow direct intravenous injection

Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Related Publications (9)

• 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.

  PMID: 28076709 BACKGROUND

• 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.

  PMID: 25075022 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28450563 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.

  PMID: 28107508 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.

  PMID: 29025982 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.

  PMID: 2576373 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.

  PMID: 20596866 BACKGROUND

Related Links

• 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

MeSH Terms

Interventions

Ga(III)-DOTATOC

Study Officials

• Loic DJAILEB

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine FAURE

CONTACT

0476766872; MFaure6@chu-grenoble.fr

Pierre PITTET

CONTACT

0476766872; ppittet@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 25 patients: 25 patients with breast cancer labeled on the primary lesion ER+HER2-

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: September 25, 2024
• Study Start: January 6, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)