89Zr-atezolizumab PET Scan and Lobular Breast Cancer

NCT04222426 | Terminated

• 1 other identifier: 201900180
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Lobular Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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. For the two different time points we will calculate the SUV for all lesions and patients. Relative decrease or increase in SUV units between different time points will be calculated for all lesions and patients, and recorded as percentage of SUV decrease or increase.

  2 years

Secondary Outcomes (2)

• The relation between standardized uptake value (SUV) on 89Zr-atezolizumab PET scan, to response to carboplatin-atezolizumab

  2 years

• The relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments

  2 years

Study Arms (1)

89Zr-atezolizumab PET scan

EXPERIMENTAL

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.

Other: 89Zr-atezolizumab PET scans

Interventions

89Zr-atezolizumab PET scans OTHER

Patients 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).

89Zr-atezolizumab PET scan

Eligibility Criteria

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

You may qualify if:

• Able to give written informed consent and to comply with the ImaGelato protocol

You may not qualify if:

• Contra-indication for 89Zr-atezolizumab PET scan
• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Study Officials

• C. P. Schröder, MD, PhD

  University Medical Center Groningen

  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: principal investigator

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: January 10, 2020
• Study Start: December 18, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

NL (1)