Imaging macrophages in lung cancer patients using a specific tracer
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)
This study is testing a special imaging tool to see if it can help doctors better understand the role of certain immune cells in lung cancer patients who are about to have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Jette, Brussels Capital) |
| Trial ID | NCT05933239 on ClinicalTrials.gov |
What this trial studies
This Phase II study aims to evaluate the effectiveness of 68GaNOTA-anti-MMR-VHH2 for imaging macrophage mannose receptor-expressing macrophages in patients with non-small cell lung cancer (NSCLC) who are scheduled for surgical resection. The study utilizes Positron Emission Tomography (PET) to visualize these macrophages, which may provide insights into the tumor microenvironment and disease progression. Eligible patients must be at least 18 years old and have tumors suitable for surgical intervention. The study seeks to enhance the understanding of macrophage involvement in lung cancer and improve surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-small cell lung cancer who are planned for surgical resection of their tumors.
Not a fit: Patients with advanced performance status, serious infections, or other life-threatening illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could lead to better assessment of tumor characteristics and potentially improve surgical planning and outcomes for lung cancer patients.
How similar studies have performed: While this approach is innovative, similar imaging techniques targeting macrophages have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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
Where this trial is running
Jette, Brussels Capital
- Universitair Ziekenhuis Brussel — Jette, Brussels Capital, Belgium (Recruiting)
Study contacts
- Principal investigator: Tony Lahoutte, MD, PhD — Universitair Ziekenhuis Brussel
- Study coordinator: UZ Brussel
- Email: nucg.clinicaltrials@uzbrussel.be
- Phone: +32 2 477 6013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.