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Clinical Trials/EUCTR2021-005575-40-BE
EUCTR2021-005575-40-BE
Active, Not Recruiting
Phase 1

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).

Z Brussel0 sites20 target enrollmentNovember 10, 2022
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Z Brussel
Enrollment
20
Status
Active, Not Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 10, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Z Brussel

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 minimize partial volume effect the diameter of the tumor 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 20
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 20

Exclusion Criteria

  • •\- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
  • •\- Pregnant patients
  • •\- Breast feeding patients
  • •\- Patients with any serious active infection
  • •\- Patient 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 best 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 with increased risk of death from a pre\-existing concurrent illness

Outcomes

Primary Outcomes

Not specified

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