Lobular Metastatic Breast CancerImaGelatoNCT04222426
89Zr-atezolizumab PET Scan and Lobular Breast Cancer
A study testing 89Zr-atezolizumab PET scans in people with Lobular Metastatic Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lobular Metastatic Breast Cancer
- What is being tested?
- 89Zr-atezolizumab PET scans
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Dec 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient must meet the inclusion criteria of the GELATO trial
- Able to give written informed consent and to comply with the ImaGelato protocol
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can 89Zr-atezolizumab PET Scan Identify Patients With Metastatic Invasive Lobular Breast Cancer Who Will Respond to Chemotherapy-immune Checkpoint Inhibition?
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
- Being tested
- 89Zr-atezolizumab PET scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-atezolizumab PET scansOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 89Zr-atezolizumab PET scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
The relation between standardized uptake value (SUV) on 89Zr-atezolizumab PET scan, to response to carboplatin-atezolizumab
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. For the 89Zr-atezolizumab PET scans, uptake will be quantified with SUV units for both time points.
Measured: 2 years
The relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments
Relation of 89Zr-atezolizumab tumor uptake at baseline and after carboplatin induction, with tumor biopsy assessments (for example PD-L1 immunohistochemistry (IHC)). We will investigate whether PD-L1 expression is associated with 89Zr-atezolizumab uptake. The relationship between tumor PD-L1 expression (measured in pre-treatment biopsy and induction treatment biopsy), and 89Zr-atezolizumab tumor uptake will be described.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start18 Dec 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: Cessation of main trial of which this study was a biomarker imaging side study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lobular Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C.P. Schroder, University Medical Center Groningen
- Investigators
- C. P. Schröder, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222426
- Sponsor's protocol ID
- 201900180
- Acronym
- ImaGelato
- Status last verified
- Jun 2022
- First submitted
- 23 Apr 2019
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can 89Zr-atezolizumab PET Scan Identify Patients With Metastatic Invasive Lobular Breast Cancer Who Will Respond to Chemotherapy-immune Checkpoint Inhibition?
- ClinicalTrials.gov ID
- NCT04222426
- Acronym / sponsor ID
- ImaGelato / 201900180
- Conditions
- Lobular Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cessation of main trial of which this study was a biomarker imaging side study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-atezolizumab PET scan | Experimental | Other: 89Zr-atezolizumab PET scansAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A patient must meet the inclusion criteria of the GELATO trial
- Able to give written informed consent and to comply with the ImaGelato protocol
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-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). | Other | 89Zr-atezolizumab PET scan |
Primary outcome
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
Time frame: 2 years
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 secondary outcomes
The relation between standardized uptake value (SUV) on 89Zr-atezolizumab PET scan, to response to carboplatin-atezolizumab
Time frame: 2 years
The relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Cessation of main trial of which this study was a biomarker imaging side study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C. P. Schröder, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-atezolizumab PET scans in people with Lobular Metastatic Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Cessation of main trial of which this study was a biomarker imaging side study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.