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Trial Title:
First Human Trial of Targeting MDM2/MDMX PET Imaging
NCT ID:
NCT06443762
Condition:
MDM2/MDMX Gene Mutation
Nuclear Medicine
Positron Emission Tomography Imaing
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga] MDM2/MDMX Peptide
Description:
Utilizing a peptide with high affinity to MDM2/MDMX as the targeting moiety for
radiopharmaceuticals, this study explores the diagnostic efficacy of [68Ga] MDM2/MDMX
Peptide in patients with malignant tumors exhibiting high MDM2/MDMX expression. This
approach not only provides a basis for the early diagnosis of malignant tumors but also
facilitates the formulation of effective precision therapy strategies tailored to the
tumor's MDM2/MDMX expression profile, particularly for patients with recurrent and
metastatic disease.
[68Ga] MDM2/MDMX Peptide, a novel MDM2/MDMX-targeted molecular probe labeled with 68Ga,
utilizes DOTA as a bifunctional chelator for complexing with 68Ga3+. The labeling process
is straightforward, allowing for direct use without purification, and demonstrates high
in vivo stability.
Arm group label:
Experimental group patients who underwent PET scanning with injection probes
Summary:
Investigation of the Radiotracer Uptake of [68Ga] MDM2/MDMX Peptide at Lesion Sites in
Patients with Malignant Tumors, and Evaluation of the Capability of [68Ga] MDM2/MDMX
Peptide to Detect Overexpression of MDM2/MDMX in Tumor Patients, Particularly Those with
Recurrent or Advanced Disease.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ages 18 to 75 years, both males and females are eligible;
2. Participants must meet the following criteria for blood routine and liver/kidney
function tests: Complete blood count: WBC ≥ 4.0 × 10^9/L or neutrophils ≥ 1.5 ×
10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L; prothrombin time (PT) or
activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal
(ULN); liver and kidney function: Total bilirubin ≤ 1.5 times the upper threshold
limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for participants with liver metastasis,
alkaline phosphatase (ALP) ≤ 2.5 ULN (if bone or liver metastases are present, ALP ≤
4.5 ULN); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;
3. Normal cardiac function;
4. An expected survival of ≥ 12 weeks;
5. Good follow-up compliance;
6. According to RECIST 1.1 criteria, there must be at least one measurable target
lesion;
7. Women of childbearing age (15-49 years) must have a negative pregnancy test
conducted within 7 days prior to enrollment; patients of childbearing potential must
agree to use effective contraceptive methods to ensure they do not conceive during
the study and for three months after examinations;
8. Patients recommended for PET/CT evaluation for tumor diagnosis and staging by a
clinician;
9. Participants must fully understand the study and voluntarily participate, and must
sign an informed consent form.
Exclusion Criteria:
1. Severe abnormalities in liver and kidney function as well as hematological
parameters;
2. Patients who are planning a pregnancy;
3. Pregnant or lactating women;
4. Individuals unable to lie flat for thirty minutes;
5. Individuals who refuse to participate in this clinical study;
6. Individuals suffering from claustrophobia or other psychiatric disorders;
7. Other conditions deemed by the researchers as unsuitable for participation in the
trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 10, 2024
Completion date:
May 30, 2025
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06443762
