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68Ga-Nota-Abscint-Her2

This article discusses a clinical trial investigating the use of 68Ga-Nota-Abscint-Her2, a radiodiagnostic agent, in PET/CT imaging for patients with metastatic breast cancer. The study aims to evaluate the diagnostic performance of this novel imaging technique in detecting HER2 expression and its potential impact on treatment decisions for patients with various subtypes of metastatic breast cancer.

Table of Contents

What is 68Ga-NOTA-ABSCINT-HER2?

68Ga-NOTA-ABSCINT-HER2, also known as 68Ga-ABS011, is a new diagnostic tool being studied for patients with metastatic breast cancer (mBC)[1]. It is a radiodiagnostic agent, which means it’s a substance that can be used to create images of the inside of your body to help doctors diagnose or monitor certain conditions[1].

Purpose of the Study

The main goal of this study is to evaluate how well 68Ga-ABS011 performs in diagnosing HER2 status in patients with metastatic breast cancer[1]. HER2 (Human Epidermal Growth Factor Receptor 2) is a protein that promotes the growth of cancer cells. Some breast cancers have higher levels of HER2, which can affect treatment decisions.

How Does It Work?

68Ga-ABS011 is used in a special type of imaging test called PET/CT (Positron Emission Tomography/Computed Tomography)[1]. This test combines two different imaging techniques to create detailed pictures of the inside of your body. The 68Ga-ABS011 is injected into your body and attaches to HER2 proteins on cancer cells. This allows doctors to see where in your body the cancer has spread and whether these cancer cells have high levels of HER2.

Potential Benefits

The use of 68Ga-ABS011 PET/CT may offer several potential benefits:

  • It could provide a more accurate picture of HER2 status across the entire body, which is important because HER2 levels can vary between different tumor sites[1].
  • It might help doctors make better decisions about treatment, especially regarding the use of HER2-targeted therapies[1].
  • It could potentially reduce the need for multiple biopsies, which can be invasive and uncomfortable[1].

Who Can Participate?

This study is designed for adult patients with metastatic breast cancer. Specifically, it includes patients with:

  • Hormone receptor-positive/HER2-negative mBC: This means the cancer grows in response to hormones but doesn’t have high levels of HER2.
  • Triple-negative mBC: This type of breast cancer doesn’t have high levels of estrogen receptors, progesterone receptors, or HER2.
  • HER2-positive mBC: This type has high levels of HER2[1].

Participants must be at least 18 years old and have at least one tumor that can be biopsied and is visible on another type of scan called FDG PET/CT[1].

Study Procedure

The study involves two main phases:

  1. Diagnostic phase: Participants will undergo several tests, including:
    • A standard FDG PET/CT scan
    • A biopsy guided by the FDG PET/CT scan
    • The new 68Ga-ABS011 PET/CT scan
    • A second biopsy guided by the 68Ga-ABS011 scan (this is optional for some patients)[1]
  2. Treatment follow-up phase: If the tests show that a patient might benefit from HER2-targeted therapy, they will receive this treatment and have another FDG PET/CT scan after 6 weeks[1].

Safety Considerations

As with any medical procedure, there are some safety considerations:

  • The study will monitor for any side effects or reactions to 68Ga-ABS011[1].
  • Patients with certain conditions, such as severely impaired kidney function or liver problems, may not be able to participate[1].
  • Pregnant or breastfeeding women cannot participate in the study[1].

It’s important to discuss any concerns or questions with your doctor before deciding to participate in this study.

Aspect Details
Study Type Phase II, interventional, prospective, single-arm radio-diagnostic study
Primary Objective Evaluate diagnostic performance of 68Ga-ABS011 PET/CT compared to standard HER2 status tests
Key Eligibility Criteria Adults with metastatic breast cancer (hormone receptor-positive/HER2-negative, triple-negative, or HER2-positive)
Main Procedures 68Ga-ABS011 PET/CT, 18F-FDG PET/CT, tumor biopsies, IHC/ISH analyses
Primary Endpoint Diagnostic agreement between 68Ga-ABS011 PET/CT and IHC/ISH HER2 status
Secondary Objectives Safety assessment, impact on treatment management, evaluation of tumor heterogeneity
Potential Impact Improved whole-body mapping of HER2 expression, potential to guide personalized treatment decisions

FAQ

  • What is the purpose of using 68Ga-Nota-Abscint-Her2 in this clinical trial? The main purpose is to evaluate how well 68Ga-Nota-Abscint-Her2 PET/CT imaging performs in detecting HER2 expression in metastatic breast cancer compared to standard tests like IHC and ISH. It also aims to assess if this imaging technique can provide a whole-body map of HER2 expression and potentially influence treatment decisions.
  • Who can participate in this clinical trial? Adult patients (18 years or older) with confirmed metastatic breast cancer are eligible. This includes patients with hormone receptor-positive/HER2-negative, triple-negative, or HER2-positive metastatic breast cancer. Participants must have at least one biopsiable, FDG-positive, non-liver metastatic lesion of 15mm or larger.
  • What procedures will participants undergo during the trial? Participants will undergo several imaging procedures, including standard 18F-FDG PET/CT scans and the investigational 68Ga-Nota-Abscint-Her2 PET/CT scan. They will also have at least one tumor biopsy. Some patients may have an additional biopsy guided by the 68Ga-Nota-Abscint-Her2 PET/CT results. Patients eligible for HER2-targeted therapy will have a follow-up scan after 6 weeks of treatment.
  • What are the potential benefits of this new imaging technique? The 68Ga-Nota-Abscint-Her2 PET/CT imaging may provide better insights into tumor heterogeneity and HER2 expression throughout the body. This could potentially lead to more accurate diagnosis and guide treatment decisions for patients with metastatic breast cancer, especially in cases where HER2 expression may vary between different tumor sites.
  • Are there any risks associated with participating in this trial? The trial involves exposure to radiation from the PET/CT scans and the radiodiagnostic agent. There are also risks associated with tumor biopsies, such as bleeding or other complications. The researchers will monitor participants for any adverse events throughout the study. Patients with certain medical conditions or those at high risk for biopsy complications are excluded from the trial to ensure safety.

Ongoing Clinical Trials on 68Ga-Nota-Abscint-Her2

  • Study on the Diagnostic Performance of 68Ga-ABS011 PET/CT for Patients with Metastatic Breast Cancer

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium

  • Testing 68Ga-NOTA-ABSCINT-HER2 Imaging to Predict Treatment Response in Patients with HER2-Positive Early Breast Cancer Receiving Chemotherapy

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • HER2: Human Epidermal Growth Factor Receptor 2, a protein that promotes the growth of cancer cells. Some breast cancers have higher levels of HER2, which can be targeted by specific treatments.
  • PET/CT: Positron Emission Tomography/Computed Tomography, an imaging technique that combines PET and CT scans to provide detailed pictures of the body's structures and functions.
  • Metastatic Breast Cancer (mBC): Breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain.
  • 68Ga-Nota-Abscint-Her2: A radiodiagnostic agent used in this study to target and visualize HER2-expressing tumors during PET/CT imaging.
  • IHC: Immunohistochemistry, a laboratory test used to detect specific proteins, such as HER2, in tissue samples.
  • ISH: In Situ Hybridization, a technique used to detect specific DNA or RNA sequences in tissue samples, often used to confirm HER2 status.
  • 18F-FDG PET/CT: A type of PET/CT scan that uses a radioactive form of glucose (18F-FDG) to detect cancer cells, which typically consume more glucose than normal cells.
  • Tumor heterogeneity: The presence of different cell populations within a tumor or between different tumor sites, which can have varying characteristics such as HER2 expression.
  • Biopsy: A medical procedure to remove a small sample of tissue from the body for examination and testing.
  • Hormone receptor-positive: Breast cancers that have receptors for estrogen or progesterone, which can influence their growth and treatment options.
  • Triple-negative breast cancer: A type of breast cancer that lacks estrogen receptors, progesterone receptors, and HER2 protein expression.

References

  1. http://clinicaltrials.eu/trial/study-on-the-diagnostic-performance-of-68ga-abs011-pet-ct-for-patients-with-metastatic-breast-cancer/