Breast CarcinomaPhase 1/2NCT03831711
68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer
A Phase 1/2 study testing Gallium Ga 68-labeled GRPR Antagonist BAY86-7548, Magnetic Resonance Imaging and Positron Emission Tomography in people with Breast Carcinoma and Estrogen Receptor Positive, run by Andrei Iagaru at 1 site in United States.
Trial summary
This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Estrogen Receptor Positive
- What is being tested?
- Gallium Ga 68-labeled GRPR Antagonist BAY86-7548, Magnetic Resonance Imaging and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 15 Nov 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ER+ breast cancer at initial diagnosis prior to surgery or at recurrence (at least one ER+ lesion based on results of biopsy).
- Able to provide written consent
- Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent)
Who cannot join
- Less than 18 years-old at the time of radiotracer administration
- Inability to lie still for the entire imaging time
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
- Renal function impairment preventing administration of MRI contrast
- Metallic implants (contraindicated for MRI)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
About this study
Official title: A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer
This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor positive primary breast cancer and metastases
OUTLINE:
Patients receive 68-Ga-RM2 intravenously (IV) and after 45 minutes undergo PET/MRI over 30-60 minutes.
After completion of study, patients are followed up at 24-72 hours, and then for 12 months.
- Conditions
- Breast Carcinoma, Estrogen Receptor Positive
- Being tested
- Gallium Ga 68-labeled GRPR Antagonist BAY86-7548, Magnetic Resonance Imaging, Positron Emission Tomography, Investigational software and coils in PET/MR scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium Ga 68-labeled GRPR Antagonist BAY86-7548Drug
Also called (68)-Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68-Ga-Bombesin Antagonist BAY86-7548, 68-Ga-DOTA RM2, 68-Ga-DOTA-Bombesin Analog BAY86-7548
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo PET/MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/MRI
Investigational software and coils in PET/MR scanDevice
General Electric (GE) Healthcare non-approved PET scanner coils and software
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (68-Ga RM2, PET/MRI) | Experimental | Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes. Receives: Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Device: Investigational software and coils in PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
Number of lesions identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start19 Mar 2019
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrei Iagaru
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor-investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, Principal investigator, Stanford Cancer Institute Palo Alto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831711
- Sponsor's protocol ID
- IRB-48150
- Other IDs
- NCI-2019-00237, BRS0098, IRB-48150
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2019
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT03831711
- Acronym / sponsor ID
- IRB-48150
- Conditions
- Breast Carcinoma, Estrogen Receptor Positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Andrei IagaruUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor positive primary breast cancer and metastases
OUTLINE:
Patients receive 68-Ga-RM2 intravenously (IV) and after 45 minutes undergo PET/MRI over 30-60 minutes.
After completion of study, patients are followed up at 24-72 hours, and then for 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (68-Ga RM2, PET/MRI) | Experimental | Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Device: Investigational software and coils in PET/MR scanPatients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ER+ breast cancer at initial diagnosis prior to surgery or at recurrence (at least one ER+ lesion based on results of biopsy).
- Able to provide written consent
- Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent)
Key exclusion criteria (6 listed)
- Less than 18 years-old at the time of radiotracer administration
- Inability to lie still for the entire imaging time
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
- Renal function impairment preventing administration of MRI contrast
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 |
|---|---|---|
| Gallium Ga 68-labeled GRPR Antagonist BAY86-7548Also: (68)-Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68-Ga-Bombesin Antagonist BAY86-7548, 68-Ga-DOTA RM2, 68-Ga-DOTA-Bombesin Analog BAY86-7548Given IV | Drug | Diagnostic (68-Ga RM2, PET/MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo PET/MRI | Procedure or surgery | Diagnostic (68-Ga RM2, PET/MRI) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/MRI | Procedure or surgery | Diagnostic (68-Ga RM2, PET/MRI) |
| Investigational software and coils in PET/MR scanGeneral Electric (GE) Healthcare non-approved PET scanner coils and software | Device | Diagnostic (68-Ga RM2, PET/MRI) |
Primary outcome
Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
Time frame: up to 2 hours
Number of lesions identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrei Iagaru principal investigator
Stanford Cancer Institute Palo Alto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gallium Ga 68-labeled GRPR Antagonist BAY86-7548, Magnetic Resonance Imaging and Positron Emission Tomography in people with Breast Carcinoma and Estrogen Receptor Positive, run by Andrei Iagaru at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 13 Dec 2023. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI (time frame: up to 2 hours). 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 13 Dec 2023.