Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients
MAGMA
A Phase II Study to Evaluate the Imaging Potential of 68GaNOTA-Anti-MMR VHH2 for in Vivo Imaging of MMR-expressing Macrophages by Means of Positron Emission Tomography (PET) in Patients With Non-small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
20
1 country
1
Brief Summary
Phase II study to evaluate the clinical potential of 68GaNOTA-anti-MMR-VHH2 for in vivo imaging of Macrophage Mannose Receptor (MMR)-expressing Macrophages by means of Positron Emission Tomography (PET) in patients with non-small cell lung cancer (NSCLC) planned for surgical resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
Started Mar 2023
Typical duration for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2023
CompletedFirst Submitted
Initial submission to the registry
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
June 17, 2024
June 1, 2024
4 years
June 27, 2023
June 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.
PET/CT and immunohistochemistry will be assessed using a (semi-)quantitative scale.
Resection of lesion up to 21 days after PET/CT
Study Arms (1)
Patients diagnosed with non-small cell lung cancer (NSCLC), planned for standard-of-care surgery
OTHERInterventions
Injection of the radiopharmaceutical and PET/CT imaging
Eligibility Criteria
You may qualify if:
- Patients who have given informed consent
- Patients at least 18 years old
- Patient with local, locally advanced or metastatic disease of non-small cell lung cancer, who is planned for resection or surgical biopsy of at least one lesion. In order to minimise partial volume effect, the diameter of the tumour to be resected or biopsied should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions
You may not qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Pregnant patients
- Breast feeding patients
- Patients with any serious active infection
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- Patients who are unlikely to cooperate with the requirements of the study
- Patients who are unwilling and/or unable to give informed consent
- Patients at increased risk of death from a pre-existing concurrent illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tony Lahoutte, MD, PhD
Universitair Ziekenhuis Brussel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 6, 2023
Study Start
March 30, 2023
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
June 17, 2024
Record last verified: 2024-06