Clinical Trials Directory

Trials / Terminated

TerminatedNCT04222426

89Zr-atezolizumab PET Scan and Lobular Breast Cancer

Can 89Zr-atezolizumab PET Scan Identify Patients With Metastatic Invasive Lobular Breast Cancer Who Will Respond to Chemotherapy-immune Checkpoint Inhibition?

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
University Medical Center Groningen · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHER89Zr-atezolizumab PET scansPatients receive a total amount of 10 mg unlabeled atezolizumab, this will be added to the tracer to prevent rapid clearance during imaging. A labeled dose of 37 Megabequerell (MBq) 89Zr-atezolizumab (±10%; 1 Millicurie) will then be administered. The tracer will be administered intravenously (i.v.). All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and one after two doses carboplatin induction treatment. After each tracer injection, 89Zr-atezolizumab PET scans will be performed on day 4 (96 ± 6h after tracer administration).

Timeline

Start date
2019-12-18
Primary completion
2022-05-01
Completion
2022-05-01
First posted
2020-01-10
Last updated
2022-07-01

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT04222426. Inclusion in this directory is not an endorsement.