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Conseils sur l'imagerie moléculaire du sein pour la biopsie mammaire chez les patientes présentant des anomalies mammaires

30 septembre 2026 mis à jour par: Mayo Clinic

Étude clinique pilote pour évaluer l'imagerie moléculaire du sein - Conseils pour l'échantillonnage des anomalies mammaires

This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken. Sometimes a lesion or part of the lesion cannot be seen on ultrasound or mammography, and, therefore, a biopsy guided with ultrasound or mammography may not be always be accurate. Studies have shown that high resolution MBI may have potential to improve the detection of some breast tumors. This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVE:

I. To evaluate a methodology for MBI-guided biopsy of suspicious breast lesions.

OUTLINE: Patients are assigned to 1 of 2 study parts.

PART I: Patients receive technetium Tc-99m sestamibi intravenously (IV) and undergo MBI on study.

PART II: Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.

After completion of study intervention, patients may be asked to follow up at 3-6 months.

Type d'étude

Interventionnel

Inscription (Estimé)

70

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • Recrutement
        • Mayo Clinic in Rochester
        • Contact:
        • Chercheur principal:
          • Katie N. Hunt, M.D.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • PART I: Women aged 18 years or older

  • PART I: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure

  • PART I: Individuals who have previously (within the last 3 years) undergo an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or follow-up) to be benign in nature

  • PART I: Individuals who have agreed to participate in the study and who have signed the study-specific informed consent

  • PART II: Women aged 18 years or older

  • PART II: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure

  • PART II: Individuals who have previously (within the last 3 years) undergone an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or follow-up) to be benign or probably benign in nature

  • PART II: Individuals who had recent conventional imaging work-up including either x-ray mammography, ultrasound, MBI, or MRI of the breast and are found to have at least one breast imaging finding for which biopsy is required or recommended, specifically:

    • Individuals who have a breast abnormality(ies) on imaging with mammography, ultrasound, MBI, or MRI (as per American College of Radiology [ACR] Breast Imaging Reporting and Data System [BIRADS] 3, or higher) and requiring imaging follow-up or biopsy confirmation

  • PART II: Individuals who have agreed to participate in the study and who have signed study-specific informed consent

Exclusion Criteria:

  • PART I: Women who are pregnant
  • PART I: Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study
  • PART I: Age less than 18 years
  • PART I: Women with breast implant(s) in the breast containing the lesion of interest
  • PART I: Inability to provide informed consent
  • PART II: Women who are pregnant
  • PART II: Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study
  • PART II: Age less than 18 years
  • PART II: Women with breast implant(s) in the breast containing the lesion of interest
  • PART II: Women who have recently (within the last 3 months) undergone biopsy of the breast finding
  • PART II: Women who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of MBI-guided biopsy
  • PART II: Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure
  • PART II: Inability to provide informed consent
  • PART II: Women who have had surgery on the study breast(s) within the past 12 months

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Part I (technetium Tc-99m sestamibi, MBI)

Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.
Radiation: Scintimammography

Undergo MBI

Autres noms:
  • MBI
  • Imagerie gamma spécifique au sein
  • Numérisation de miraluma
  • Test de miraluma
  • Imagerie moléculaire du sein
  • Imagerie mammaire en médecine nucléaire
  • imagerie mammaire au sestamibi
  • Scintimammographie Sestamibi
Autre: Technetium Tc-99m Sestamibi

Given IV

Autres noms:
  • Cardiolite
  • Miralum
  • Tc 99m Sestamibi
  • Tc-99m MIBI
  • Tc99m Sestamibi
  • Technétium (99mTc) Sestamibi
  • 99m Tc-méthoxy isobutylisonitrile
Expérimental: Part II (technetium Tc-99m sestamibi, MBI, biopsy)

Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.
Radiation: Scintimammography

Undergo MBI

Autres noms:
  • MBI
  • Imagerie gamma spécifique au sein
  • Numérisation de miraluma
  • Test de miraluma
  • Imagerie moléculaire du sein
  • Imagerie mammaire en médecine nucléaire
  • imagerie mammaire au sestamibi
  • Scintimammographie Sestamibi
Autre: Technetium Tc-99m Sestamibi

Given IV

Autres noms:
  • Cardiolite
  • Miralum
  • Tc 99m Sestamibi
  • Tc-99m MIBI
  • Tc99m Sestamibi
  • Technétium (99mTc) Sestamibi
  • 99m Tc-méthoxy isobutylisonitrile
Procédure: Biopsy of Breast

Undergo biopsy of breast

Autres noms:
  • Biopsie mammaire
Autre: Medical Device Usage and Evaluation

Utilization of the Stereo Navigator accessory

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Validation of timeframe
Délai: Baseline

Time from injection of the technetium Tc-99m sestamibi to identification of the appropriate needle guide hole will be reviewed to determine if and where any improvements in workflow can be made to reduce the overall procedure time for patients.
Baseline
Change in image of lesion
Délai: Baseline; Up to 6 months

The coordinates of the lesion of interest on the high resolution MBI image will be recorded. The guidance procedure will be considered successful if 1) the pre and post images of the lesion demonstrated one of the following: decreased in size, central or eccentric defect where sampled, or decrease in intensity, or 2) pathology results demonstrate malignancy or a specific benign concordant result.
Baseline; Up to 6 months
Accuracy of depth estimation by difference in attenuation from opposing views
Délai: Baseline; Up to 6 months

For each patient in whom pathology confirms successful sampling of the lesion seen on high-resolution molecular breast imaging (MBI), the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.
Baseline; Up to 6 months
Accuracy of depth estimation by difference in apparent lesion size
Délai: Baseline; Up to 6 months

For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.
Baseline; Up to 6 months
Accuracy of depth estimation by triangulation
Délai: Baseline; Up to 6 months

For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.
Baseline; Up to 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Mayo Clinic

Les enquêteurs

  • Chercheur principal: Katie N. Hunt, M.D., Mayo Clinic in Rochester

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 août 2021

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

13 septembre 2023

Première soumission répondant aux critères de contrôle qualité

22 septembre 2023

Première publication (Réel)

28 septembre 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 18-011329
  • 18-011329 (Autre identifiant: Mayo Clinic in Rochester)
  • NCI-2023-06047 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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