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Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients (MAGMA)

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
68GaNOTA-Anti-MMR-VHH2
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring PET/CT, MMR-PET/CT, Macrophage PET/CT, CD206

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who have given informed consent Patients at least 18 years old Patient with local, locally advanced or metastatic disease of 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 Patients who participated already in this study can be included if the subject meets all of the inclusion and none of the exclusion criteria at time of second inclusion. Exclusion Criteria: 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

Sites / Locations

  • Universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients diagnosed with non-small cell lung cancer (NSCLC), planned for standard-of-care surgery

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2023
Last Updated
June 27, 2023
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05933239
Brief Title
Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients
Acronym
MAGMA
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
PET/CT, MMR-PET/CT, Macrophage PET/CT, CD206

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients diagnosed with non-small cell lung cancer (NSCLC), planned for standard-of-care surgery
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
68GaNOTA-Anti-MMR-VHH2
Intervention Description
Injection of the radiopharmaceutical and PET/CT imaging
Primary Outcome Measure Information:
Title
Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.
Description
PET/CT and immunohistochemistry will be assessed using a (semi-)quantitative scale.
Time Frame
Resection of lesion up to 21 days after PET/CT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have given informed consent Patients at least 18 years old Patient with local, locally advanced or metastatic disease of 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 Patients who participated already in this study can be included if the subject meets all of the inclusion and none of the exclusion criteria at time of second inclusion. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UZ Brussel
Phone
+32 2 477 6013
Email
nucg.clinicaltrials@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens M Debacker, MD, PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens M Debacker, MD, PhD
Phone
+32 2 477 6013
Email
nucg.clinicaltrials@uzbrussel.be

12. IPD Sharing Statement

Learn more about this trial

Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients

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