89Zr-atezolizumab PET Scan and Lobular Breast Cancer (ImaGelato)

University Medical Center Groningen (UMCG)

Status: Terminated

Conditions: Lobular Metastatic Breast Cancer

Treatments: Other: 89Zr-atezolizumab PET scans

Study type: Interventional

Funder types: Other

Identifiers

NCT04222426

201900180

Details and patient eligibility

About

The exploratory single center feasibility ImaGelato study is conducted as an imaging side study to the Dutch GELATO trial (Assessing efficacy of carboplatin and atezolizumab in metastatic lobular breast cancer). Ten patients with lobular metastatic breast cancer, who are included in the GELATO trial at the UMCG, are eligible for the ImaGelato study.

All patients will undergo two Zirconium-89 (89Zr)-atezolizumab positron emission tomography (PET) scans, one at baseline and one after two doses carboplatin induction treatment. The 89Zr-atezolizumab PET scan will be performed 4 days after tracer injection. Procedures within the ImaGelato study will be completed after the two 89Zr-atezolizumab PET scans, but patients will continue treatment with carboplatin combined with atezolizumab in the GELATO trial.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A patient must meet the inclusion criteria of the GELATO trial
2. Able to give written informed consent and to comply with the ImaGelato protocol

Exclusion criteria

1. Contra-indication for 89Zr-atezolizumab PET scan
2. Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤14 days prior to the first 89Zr-atezolizumab injection. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the first 89Zr-atezolizumab injection.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

89Zr-atezolizumab PET scan

Experimental group

Description:

All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and one after two doses carboplatin induction treatment. The 89Zr-atezolizumab PET scan will be performed 4 days after tracer injection. Procedures within the ImaGelato study will be completed after the two 89Zr-atezolizumab PET scans, but patients will continue treatment with carboplatin combined with atezolizumab in the GELATO trial.

Treatment:

Other: 89Zr-atezolizumab PET scans