Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Esophageal Neoplasms Gastric Neoplasms Malignant HER2-positive Gastric Cancer

Keywords

68-Ga ABY-025HER2 PETPET/CTGastroesophageal cancerMetastatic breast cancerHER2 low

Outcome Measures

Primary Outcomes (1)

Percentage of HER2-positive lesions
Percentage of HER2-positive lesions (primary tumors and/or metastases) measured by tracer uptake on PET/CT which are also positive regarding HER2-status defined by reference biopsy-based standard used in clinical routine in patients with GEAC
up to 24 months

Secondary Outcomes (6)

SUV
up to 24 months
TBR
up to 24 months

Study Arms (1)

Patients with HER2 positive GEAC or HER2 low cancer (pilot)

EXPERIMENTAL

The participants of the study will undergo two sessions of HER2 PET and one 18F-FDG PET/CT for study purposes. The first HER2 PET is performed within 21 days before initiation of the systemic oncological treatment including HER2-targeted drugs, and is followed by tumor biopsies. A second HER2 PET and a second 18F-FDG PET will be performed adjacent to response evaluation after 3 courses of oncological therapy. Data from the PET investigations will be compared to HER2 expression analyses of the biopsy specimen and correlated to disease and survival data at follow up one year after inclusion. Within the pilot study, participants with HER2 low mBC will undergo one HER2 PET followed by biopsies.

Diagnostic Test: [68Ga]Ga-ABY-025 PETDiagnostic Test: Biopsy and analysis of HER2 expression

Interventions

[68Ga]Ga-ABY-025 PETDiagnostic test

\[68Ga\]Ga-ABY-025 PET: Each patient in Cohort 1 will be imaged with a PET/CT twice using the radiolabeled investigational product ABY-025 as a tracer. At the time of injection, a 45-minutes long dynamic scan will take place over a pre specified region of interest. Three hours after injection a full body PET scan followed by a CT scan will be performed.

Also known as: HER2 PET

Patients with HER2 positive GEAC or HER2 low cancer (pilot)

Biopsy and analysis of HER2 expressionDiagnostic test

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥18 years.
The subject has given written consent to participate in the study.

Sponsors & Collaborators

Karolinska University Hospital
Otherlead

Study Sites (1)

Department of Radiation Physics and Nuclear Medicine, Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

Rimma Axelsson, ProfCONTACT+46858580000 rimma.axelsson@ki.se

Siri af Burén, MDCONTACT+46739099570 siri.afburen@regionstockholm.se

Rimma Axelsson, ProfessorPRINCIPAL INVESTIGATOR

Renske Althena, MD, PhDSUB INVESTIGATOR

Magnus Nilsson, ProfessorSUB INVESTIGATOR

Related Publications (10)

Velikyan I, Schweighofer P, Feldwisch J, Seemann J, Frejd FY, Lindman H, Sorensen J. Diagnostic HER2-binding radiopharmaceutical, [68Ga]Ga-ABY-025, for routine clinical use in breast cancer patients. Am J Nucl Med Mol Imaging. 2019 Feb 15;9(1):12-23. eCollection 2019.
PMID: 30911434BACKGROUND
Alhuseinalkhudhur A, Lubberink M, Lindman H, Tolmachev V, Frejd FY, Feldwisch J, Velikyan I, Sorensen J. Kinetic analysis of HER2-binding ABY-025 Affibody molecule using dynamic PET in patients with metastatic breast cancer. EJNMMI Res. 2020 Mar 23;10(1):21. doi: 10.1186/s13550-020-0603-9.
PMID: 32201920BACKGROUND

MeSH Terms

Conditions

Esophageal NeoplasmsBreast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Rimma Axelsson, Prof., MD
Karolinska University Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Rimma Axelsson, Prof., MD

CONTACT

+46 8 585 800 00 rimma.axelsson@ki.se

Siri af Burén, MD

CONTACT

+46739099570

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Masking Details: Treating clinicians will be blinded for the results of the HER2-PET
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 16, 2022

Study Start

You may not qualify if:

Significantly impaired renal function (GFR \<30 ml/min/1.73 m2)
Allergy to iodinated contrast media
Subjects that for some reason are unable to exercise their rights, such as cognitive function impairment.
Other manifest malignancy except for basal cell carcinoma of the skin.
The patient presenting any contraindication for the use of HER2 targeted therapy for metastatic disease: congestive heart failure, baseline left ventricular ejection fraction (LVEF) less than 50%, transmural myocardial infarction, uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg), angina pectoris requiring medication, clinically significant valvular heart disease, high-risk arrhythmias, lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, active gastrointestinal bleeding.
Inadequate organ function, suggested by the following laboratory results: absolute neutrophil count \<1,500 cells/mm3, haemoglobin \<90 g/L, total bilirubin ≥1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome), Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) \>5.0 x ULN.
Positive pregnancy test in women of childbearing potential (premenopausal or \<12 months of amenorrhea post-menopause and who have not undergone surgical sterilization), or lactation.
Female patients of childbearing potential and sexually active and not willing to use a highly effective contraceptive. Examples of highly effective contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period.
Patients with increased risk of complications from biopsies, i.e. increased risk of bleeding, defined as
prothrombin time test (INR value) \>1.4, platelet count \<70 (109/l), activated partial thromboplastin time (APTT) \>30s.
known bleeding disorder such as hemophilia, von Willebrand disease or platelet disorders.
any anticoagulants or antiplatelet treatment (except for low-dose acetyl-salicylic acid (ASA), i. e 75 mg daily).

[68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Patients with HER2 positive GEAC or HER2 low cancer (pilot)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (6)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Patients with HER2 positive GEAC or HER2 low cancer (pilot)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (6)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations