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Can 89Zr-atezolizumab PET scan identify patients with metastatic invasive lobular breast cancer who will respond to chemotherapy-immune checkpoint inhibition?

Can 89Zr-atezolizumab PET scan identify patients with metastatic invasive lobular breast cancer who will respond to chemotherapy-immune checkpoint inhibition? - ImaGelato study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47947
Enrollment
10
Registered
2019-04-11
Start date
2019-12-18
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lobular breast cancer

Interventions

All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and one after two doses carboplatin induction treatment. The PET scan will be performed 4 days after tracer injection.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. A patient must meet the inclusion criteria of the GELATO trial (see in attachment the protocol) 2. Able to give written informed consent and to comply with the ImaGelato protocol

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after two carboplatin induction treatments, defined as decline or increase of standardized uptake value (SUV) of 30% or more, described as per lesion and per patient.

Secondary

MeasureTime frame
* Relation of 89Zr-atezolizumab tumor uptake (at baseline, after carboplatin induction, and change between the two scans) per lesion and per patient with response to carboplatin-atezolizumab per lesion and per patient. * Relation of 89Zr-atezolizumab tumor uptake at baseline and after carboplatin induction, with tumor biopsy assessments (PD-L1 IHC, mRNA and other potential markers of interest in the setting of immune response such as macrophages).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)