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NCT Number: NCT06611891

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

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHU Grenoble Alpes

Grenoble, 38043, France

Location status: Recruiting

Location contact

Emmanuelle JACQUET, MD, PHD

CONTACT

[email protected]

0476765451

Emmanuelle JACQUET, MD, PHD

SUB_INVESTIGATOR

Loic DJAILEB, MD, PHD

CONTACT

[email protected]

0476765455

Loic DJAILEB, MD, PHD

PRINCIPAL_INVESTIGATOR

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

68Ga-DOTATOC

Drug

Slow direct intravenous injection

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: Baseline (during the PET examination)

    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).

  2. 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)

    Disease volume per patient with overexpression of SST2 receptors in 68Ga-DOTATOC PET compared to metabolic volume in 18F-FDG PET

  3. Expression of SST2 receptors of lesions as a function of different metastatic sites, via the Krenning score

    Time frame: Baseline (during the PET examination)

    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)

  4. 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)

    PET quantification parameters (SUV max and SUV mean)

  5. 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)

    Comparison between 68Ga-DOTATOC PET and 18F-FDG PET (Krenning score and PET quantification parameter) per lesion and per patient.

  6. Clinica predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient

    Time frame: Baseline (during the PET examination)

    Clinical data prior to PET at 68Ga-DOTATOC per patient

  7. Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient

    Time frame: Baseline (during the PET examination)

    Biological data prior to PET at 68Ga-DOTATOC per patient

  8. Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient

    Time frame: Baseline (during the PET examination)

    Histological data prior to PET at 68Ga-DOTATOC per patient

  9. Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient

    Time frame: Baseline (during the PET examination)

    Imaging data prior to PET at 68Ga-DOTATOC per patient

  10. Clinical predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion

    Time frame: Baseline (during the PET examination)

    Clinical data prior to PET at 68Ga-DOTATOC per lesion

  11. Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion

    Time frame: Baseline (during the PET examination)

    Biological data prior to PET at 68Ga-DOTATOC per lesion

  12. Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion

    Time frame: Baseline (during the PET examination)

    Histological data prior to PET at 68Ga-DOTATOC per lesion

  13. Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion

    Time frame: Baseline (during the PET examination)

    Imaging data prior to PET at 68Ga-DOTATOC per lesion

Study contacts

Contact information is provided by the study sponsor or research team.

Marine FAURE

CONTACT

[email protected]

0476766872

Pierre PITTET

CONTACT

[email protected]

0476766872

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: DOTABREAST

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 25, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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