Breast Cancer MetastaticPhase 3DOTABREASTNCT06611891
Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
A Phase 3 study testing 68Ga-DOTATOC in people with Breast Cancer Metastatic, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- 68Ga-DOTATOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2025to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, 38043
Loic DJAILEB, MD, PHD, 0476765455, ldjaileb@chu-grenoble.fr
Emmanuelle JACQUET, MD, PHD, 0476765451, ejacquet1@chu-grenoble.fr
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer Metastatic
- Being tested
- 68Ga-DOTATOC
- Keywords
- Breast Cancer Metastatic, Somatostatin Receptor Expression, PET-SCAN, 68Ga-DOTATOC, Nuclear Oncology, 177-Lu-Oxodotreotide, DOTATOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATOCDrug
Slow direct intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 68Ga-DOTATOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer
Krenning Score >2
Measured: Baseline (during the PET examination)
Secondary outcomes (13)
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).
Measured: Baseline (during the PET examination)
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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (during the PET examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start6 Jan 2025
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 25 patients: 25 patients with breast cancer labeled on the primary lesion ER+HER2-
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loic DJAILEB, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611891
- Sponsor's protocol ID
- 38RC21.0432
- Acronym
- DOTABREAST
- Status last verified
- Feb 2025
- First submitted
- 20 Apr 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28107508Hope 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.
PubMed 29025982Ozelius 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.
PubMed 2576373Virgolini 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.
PubMed 20596866Strosberg 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.
PubMed 28076709Frati 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.
PubMed 25075022Dude 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.
PubMed 29503845Sollini 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.
PubMed 24693229Dalm 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.
PubMed 28450563
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06611891
- Acronym / sponsor ID
- DOTABREAST / 38RC21.0432
- Conditions
- Breast Cancer Metastatic
- Keywords
- Breast Cancer Metastatic, Somatostatin Receptor Expression, PET-SCAN, 68Ga-DOTATOC, Nuclear Oncology, 177-Lu-Oxodotreotide, DOTATOC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 25 patients: 25 patients with breast cancer labeled on the primary lesion ER+HER2-
| Arm | Type | Receives |
|---|---|---|
| Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer. | Experimental | Drug: 68Ga-DOTATOC1. 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTATOCSlow direct intravenous injection | Drug | Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer. |
Primary outcome
Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer
Time frame: Baseline (during the PET examination)
Krenning Score >2
13 secondary outcomes
Distribution of SST2 receptor overexpression by 68Ga-DOTATOC PET compared to 18F-FDG PET lesions.
Time frame: Baseline (during the PET examination)
Disease proportion with SST2 receptor overexpression by 68Ga-DOTATOC PET compared to known metastatic disease by 18F-FDG PET
Time frame: Baseline (during the PET examination)
Expression of SST2 receptors of lesions as a function of different metastatic sites, via the Krenning score
Time frame: Baseline (during the PET examination)
Expression of SST2 receptors of lesions as a function of different metastatic sites, via the PET quantification parameters.
Time frame: 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.
Time frame: Baseline (during the PET examination)
Clinica predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
Time frame: Baseline (during the PET examination)
Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
Time frame: Baseline (during the PET examination)
Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
Time frame: Baseline (during the PET examination)
Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
Time frame: Baseline (during the PET examination)
Clinical predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
Time frame: Baseline (during the PET examination)
Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
Time frame: Baseline (during the PET examination)
Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
Time frame: Baseline (during the PET examination)
Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
Time frame: Baseline (during the PET examination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Background: PubMed 28107508Dalm 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.
- Background: PubMed 29025982Hope 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.
- Background: PubMed 2576373Ozelius 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.
- Background: PubMed 20596866Virgolini 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.
- Results publication: PubMed 28076709Strosberg 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.
- Results publication: PubMed 25075022Frati 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.
- Results publication: PubMed 29503845Dude 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.
- Results publication: PubMed 24693229Sollini 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.
- Results publication: PubMed 28450563Dalm 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.
- Fiche info - SOMAKIT TOC 40 microgrammes, trousse pour préparation radiopharmaceutique - Base de données publique des médicaments.Link provided by the sponsor.
- 111In-Pentetreotide Scintigraphy Versus 68Ga-DOTATATE PET: Impact on Krenning Scores and Effect of Tumor BurdenLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Loic DJAILEB principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 68Ga-DOTATOC in people with Breast Cancer Metastatic, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine FAURE (0476766872, MFaure6@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer (time frame: Baseline (during the PET examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611891, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.