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

NCT ID: NCT05933239

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2027-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

68GaNOTA-Anti-MMR-VHH2

Intervention Type DRUG

Injection of the radiopharmaceutical and PET/CT imaging

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68GaNOTA-Anti-MMR-VHH2

Injection of the radiopharmaceutical and PET/CT imaging

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tony Lahoutte, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

UZ Brussel

Role: CONTACT

+32 2 477 6013

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tony Lahoutte, MD, PhD

Role: primary

+32 2 477 6013

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UZBRU_VHH2_4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CD8 PET Imaging in Metastatic Solid Tumours
NCT06534190 RECRUITING PHASE2
PET CT With HX4 in Cervix Cancer
NCT02233387 TERMINATED PHASE2
99mTc-3PRGD2 SPECT/CT in Lung Cancer Patients
NCT01737112 UNKNOWN EARLY_PHASE1