Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04168528
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Kom Op Tegen Kanker
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief Summary:
Phase I/IIa study to evaluate the uptake of 68NOTA-anti-MMR-VHH2, a new tracer for positron emission tomographic imaging (PET/CT scan) of breast cancer, head and neck cancer or melanoma

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Breast Cancer Head and Neck Cancer Melanoma (Skin) Drug: 68GaNOTA-Anti-MMR-VHH2 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase I/IIa Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of 68GaNOTA-Anti-MMR-VHH2, a Radiopharmaceutical for in Vivo Imaging of Tumour-Associated Macrophages by Means of PET: UZBRU_VHH2_1
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part I: safety, tolerability, biodistribution and dosimetry
Phase I
Drug: 68GaNOTA-Anti-MMR-VHH2
Injection of the radiopharmaceutical and PET/CT imaging

Experimental: Part II: tumor targeting potential and correlation to ICH
Phase II
Drug: 68GaNOTA-Anti-MMR-VHH2
Injection of the radiopharmaceutical and PET/CT imaging




Primary Outcome Measures :
  1. Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I). [ Time Frame: Before injection up until 6 hrs after injection ]
    Assessed using physical examination and blood sampling for hematology and clinical chemistry.

  2. Human biodistribution using blood sampling and PET/CT imaging: reported as relative uptake values per organ at 10, 90 and 150 minutes per individual subject and as a mean over all subjects (Part I). [ Time Frame: Immediately after injection up to 3 hrs after injection ]
    Measured in standard uptake values in PET/CT imaging and expressed in relation to the injected activity.

  3. Human dosimetry using PET/CT imaging data: radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). [ Time Frame: 10 min up to 3 hrs after injection ]
    Dosimetry will be calculated using the OLINDA software.

  4. Tumor targeting potential using PET/CT and correlation to immunohistological MMR staining after resection: assessed using correlation coefficient (Part II). [ Time Frame: Resection of lesion up to 14 days after PET/CT ]
    PET/CT and immunohistochemistry will be assessed using a semi-quantative scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PART I:

Inclusion Criteria:

Patients will only be included in the study if they meet all of the following criteria:

  • Patients who have given informed consent
  • Patients at least 18 years old
  • Patients with local, locally advanced or metastatic disease of a malignant solid tumor. In order to minimize partial volume effect the diameter of at least 1 tumor lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.

Exclusion Criteria:

Patients will not be included in the study if one of the following criteria applies:

  • Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
  • Pregnant patients
  • Breast feeding patients
  • Patients with abnormal liver (Bilirubin ≥1.5 x ULN, ALT (SGPT) ≥3 x ULN) or kidney function (Serum creatinine clearance ≤50 ml/min as calculated with Cockcroft-Gault formula)
  • Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
  • 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 cannot communicate reliably with the investigator
  • 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
  • Patients who participated already in this study

PART II:

Inclusion Criteria:

Patients will only be included in the study if they meet all of the following criteria:

  • Patients who have given informed consent
  • Patients at least 18 years old
  • Patients with local, locally advanced or metastatic disease of breast cancer, head-and-neck cancer or melanoma, 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.

Exclusion Criteria:

Patients will not be included in the study if one of the following criteria applies:

  • Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
  • Pregnant patients
  • Breast feeding patients
  • Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
  • 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 cannot communicate reliably with the investigator
  • 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
  • Patients who participated already in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168528


Contacts
Layout table for location contacts
Contact: UZ Brussel +3224776013 afspraak_nucleaire@uzbrussel.be

Locations
Layout table for location information
Belgium
Uz Brussel Recruiting
Brussels, Belgium, 1090
Contact: UZ Brussel    +3224776013    afspraak_nucleaire@uzbrussel.be   
Contact: MD         
Principal Investigator: Marleen KEYAERTS, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Kom Op Tegen Kanker
Investigators
Layout table for investigator information
Principal Investigator: Marleen KEYAERTS, MD Universitair Ziekenhuis Brussel
Layout table for additonal information
Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04168528    
Other Study ID Numbers: UZBRU_VHH2_1
2017-001471-23 ( EudraCT Number )
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitair Ziekenhuis Brussel:
PET/CT
MMR-PET/CT
Macrophage PET/CT
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site