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HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02095210
Recruitment Status : Terminated (slow recruitment)
First Posted : March 24, 2014
Last Update Posted : October 5, 2020
Information provided by (Responsible Party):
Dorte Nielsen, Herlev Hospital

Brief Summary:
This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. A [18F]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of possible metastases. Each subject will receive a single injection of the investigational product [68Ga]ABY-025, followed by measurement of uptake in the tumour or metastases and in normal organs. The investigations will be repeated after HER2 directed therapy.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Other: Radiolabeled [68Ga]ABY-025 Phase 1

Detailed Description:
see above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 1 Study, Evaluating HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025
Actual Study Start Date : August 2011
Actual Primary Completion Date : August 13, 2014
Actual Study Completion Date : August 13, 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: [68Ga]ABY-025 PET imaging
Radiolabeled [68Ga]ABY-025
Other: Radiolabeled [68Ga]ABY-025
Single dose of 100 μg ABY-025 labeled with 500 MBq gallium-68, administrated as a slow intravenous injection. All patients will receive the same dose.
Other Name: tracer for HER2

Primary Outcome Measures :
  1. to evaluate the uptake distribution of the HER2-binding imaging agent [68Ga]ABY-025 by PET imaging in breast cancer patients with biopsy-identified HER2 expression [ Time Frame: 28 days from last dose of study drug ]

Secondary Outcome Measures :
  1. Assess concordance of [68Ga]ABY-025 uptake with [18F]FDG PET uptake before and after HER2 therapy [ Time Frame: within 14 days before study drug ]
  2. 2. pharmacokinetics of [68Ga]ABY-025 and whole-body dosimetry of [68Ga]ABY-025 [ Time Frame: 6 weeks after last dose of study drug ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is > 18 years of age
  2. Histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (LABC: T3-4NxMx or TxN2-3Mx)
  3. HER2-positiv breast cancer first recurrence
  4. HER2-positiv breast cancer primary metastatic
  5. HER2 status has been determined on biopsy material from the primary tumour and found to be HER2-positive, defined as a DAKO HercepTest™ score of 3+ or else 2+ and FISH positive
  6. [18F]FDG PET/ceCT performed within 7 days before administration of IMP
  7. ECOG performance status of =< 2
  8. Hematological, liver and renal function test results within the following limits:

    • White blood cell count: > 2.0 x 10^9/L
    • Haemoglobin: > 5.0 mmol/L
    • Platelets: > 50.0 x 10^9/L
    • ALT, ALP: =< 3 times Upper Limit of Normal
    • Bilirubin =< 2.0 times Upper Limit of Normal
    • Serum creatinine: Within Normal Limits
  9. A negative pregnancy test (serum beta-HCG) at screening for all subjects of childbearing potential
  10. Subject is capable to undergo the diagnostic investigations to be performed in the study
  11. Informed consent

Exclusion Criteria:

  • 1. Known hypersensitivity to Dotarem® 2. Active known autoimmune disease or history of autoimmune disease 3. Active serious infection according to investigator evaluation 4. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Pregnant or breast-feeding 7. Women capable of childbearing not using a sufficient non-hormonal method of birth control 8. Other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin 9. Signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the IMP, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02095210

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Herlev University Hospital, Oncology Department
Herlev, Denmark, 2730
Sponsors and Collaborators
Dorte Nielsen
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Principal Investigator: Malgorzata K Tuxen, MD, P.hd. Consultant
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Responsible Party: Dorte Nielsen, Professor, Herlev Hospital Identifier: NCT02095210    
Other Study ID Numbers: MA1021
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Keywords provided by Dorte Nielsen, Herlev Hospital:
PET scan
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases