89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study

NCT05955833 | Completed

• 1 other identifier: NL82608.018.22
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a PET-scan. For this research, the investigators make PET-scans in people with HER2-positive, metastasized breast- or gastric cancer. The investigators will investigate if the new HER2-tracer correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain HER2-directed therapies. Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 60 minutes. The PET-scans are on separate days within a week after injection of the tracer (e.g. 1 day, 2 days and 4 days after injection). Furthermore, the investigators will take 7 blood samples (5 mL each). Participants are not required to stay at the hospital. The first 3 participants will undergo an extra PET-scan 1 - 2 hours after injection. The amount of radioactivity injected will be 37 MBq (± 10%).

Conditions

Breast Cancer; Metastatic Breast Cancer; Gastric Cancer; HER2-positive Breast Cancer; Metastatic Gastric Cancer; HER2-positive Gastric Cancer

Keywords

PET Imaging; HER2; DFO*; trastuzumab

Outcome Measures

Primary Outcomes (2)

• 89Zr-DFO*-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool.

  SUVmean on day 4 post injection.

• 89Zr-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool in historical controls with HER2+ breast cancer (n = 20) who underwent 89Zr-trastuzumab PET imaging.

  SUVmean on day 4 post injection.

Secondary Outcomes (13)

• Tumor uptake: 89Zr-DFO*-trastuzumab uptake (SUV, %ID/kg) in tumor lesions

  SUV on day 4 post injection.

• Tumor uptake: 89Zr-trastuzumab uptake (SUV, %ID/kg) in tumor lesions in historical controls with HER2+ breast cancer (n = 20) who underwent 89Zr-trastuzumab PET imaging.

  SUV on day 4 post injection.

• Whole blood pharmacokinetics (PK) of 89Zr-DFO*-trastuzumab (Maximum Plasma Concentration (Cmax) µg/mL)

  PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).

• Whole blood PK of 89Zr-DFO*-trastuzumab (AUC µg/mL × h)

  PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).

• Plasma PK of 89Zr-DFO*-trastuzumab (Cmax in µg/mL)

  PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).

Study Arms (1)

89Zr-DFO*-trastuzumab PET

EXPERIMENTAL

Patients undergoing the 89Zr-DFO\*-trastuzumab PET-scans

Diagnostic Test: 89Zr-DFO*-trastuzumab PET scan

Interventions

89Zr-DFO*-trastuzumab PET scan DIAGNOSTIC_TEST

Patients will be administered 37 MBq 89Zr-DFO\*-trastuzumab and undergo 3 PET scans on the total body PET scanner at day 1, day 2 and day 4 post-injection (p.i.). The first 3 patients will undergo an additional PET 1-2 h p.i. for dosimetry purposes. Three scans are needed for PK modelling and day 4 p.i. is chosen because it is the same time point as in historical controls. Blood samples for (radioactive) PK analysis will be taken at 10 min, 30 min, 1 h and 2 h p.i., and at every PET scan.

89Zr-DFO*-trastuzumab PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HER2+ breast cancer with metastatic disease starting (new) systemic treatment or
• HER2+ metastatic gastric cancer starting (new) systemic treatment.
• A recent (\< 8 weeks of start of study) biopsy confirming HER2+.
• Able to undergo PET imaging procedures.
• At least one lesion of at least 1.5 cm amenable for PET imaging
• Age \>18 years of age, willing and able to comply with the protocol as judged by the investigator.
• Signed written informed consent.
• Have a World Health Organisation (WHO) performance status of 0-2.
• Life expectancy of \> 3 months.
• Have measurable disease based on RECIST 1.1.
• Adequate organ and bone marrow function, as deemed acceptable by the treating physician
• Women aged \<50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.
• Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago.
• Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
• Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP.

You may not qualify if:

• Contraindications for systemic treatment (as will be assigned by treating physician).
• Pregnant or lactating women.
• Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
• Inability to comply with study procedures.
• Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• AstraZeneca: collaborator

Study Sites (1)

AmsterdamUMC

Amsterdam, North Holland, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• C.W. Menke-van der Houven van Oordt, MD, PhD

  AmsterdamUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 21, 2023
• Study Start: June 26, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)