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

February 27, 2025 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38043
        • Recruiting
        • CHU Grenoble Alpes
        • Contact:
        • Contact:
        • Contact:
          • Loic DJAILEB, MD, PHD
        • Contact:
          • Emmanuelle JACQUET, MD, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: 68Ga-DOTATOC
Slow direct intravenous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline (during the PET examination)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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)
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
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)
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)
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.
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.
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)
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
Time Frame: Baseline (during the PET examination)
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
Time Frame: Baseline (during the PET examination)
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
Time Frame: Baseline (during the PET examination)
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
Time Frame: Baseline (during the PET examination)
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
Time Frame: Baseline (during the PET examination)
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
Time Frame: Baseline (during the PET examination)
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
Time Frame: Baseline (during the PET examination)
Imaging data prior to PET at 68Ga-DOTATOC per lesion
Baseline (during the PET examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Loic DJAILEB, CHU Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC21.0432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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