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

Primary Purpose

Malignant Solid Tumor, Breast Cancer, Head and Neck Cancer

Status

Recruiting

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

68GaNOTA-Anti-MMR-VHH2

About this trial

This is an interventional diagnostic trial for Malignant Solid Tumor focused on measuring PET/CT, MMR-PET/CT, Macrophage PET/CT

Eligibility Criteria

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

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

Sites / Locations

Uz BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part I: safety, tolerability, biodistribution and dosimetry

Part II: tumor targeting potential and correlation to IHC

Arm Description

Phase I

Phase II

Outcomes

Primary Outcome Measures

Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I).

Assessed using physical examination and blood sampling for hematology and clinical chemistry.

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).

Measured in standard uptake values in PET/CT imaging and expressed in relation to the injected activity.

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).

Dosimetry will be calculated using the OLINDA software.

Tumor targeting potential using PET/CT and correlation to immunohistological MMR staining after resection: assessed using correlation coefficient (Part II).

PET/CT and immunohistochemistry will be assessed using a semi-quantitative scale.

Secondary Outcome Measures

Full Information

NCT ID

NCT04168528

First Posted

November 7, 2019

Last Updated

July 10, 2023

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Kom Op Tegen Kanker

1. Study Identification

Unique Protocol Identification Number

NCT04168528

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 5, 2019 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Kom Op Tegen Kanker

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Solid Tumor, Breast Cancer, Head and Neck Cancer, Melanoma (Skin)

Keywords

PET/CT, MMR-PET/CT, Macrophage PET/CT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part I: safety, tolerability, biodistribution and dosimetry

Arm Type

Experimental

Arm Description

Phase I

Arm Title

Part II: tumor targeting potential and correlation to IHC

Arm Type

Experimental

Arm Description

Phase II

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

Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I).

Description

Assessed using physical examination and blood sampling for hematology and clinical chemistry.

Time Frame

Before injection up until 6 hrs after injection

Title

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).

Description

Measured in standard uptake values in PET/CT imaging and expressed in relation to the injected activity.

Time Frame

Immediately after injection up to 3 hrs after injection

Title

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).

Description

Dosimetry will be calculated using the OLINDA software.

Time Frame

10 min up to 3 hrs after injection

Title

Tumor targeting potential using PET/CT and correlation to immunohistological MMR staining after resection: assessed using correlation coefficient (Part II).

Description

PET/CT and immunohistochemistry will be assessed using a semi-quantitative scale.

Time Frame

Resection of lesion up to 14 days after PET/CT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

UZ Brussel

Phone

+3224776013

nucgmail@uzbrussel.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marleen KEYAERTS, MD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uz Brussel

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

UZ Brussel

Phone

+3224776013

nucgmail@uzbrussel.be

First Name & Middle Initial & Last Name & Degree

Marleen KEYAERTS, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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