First Human Trial of Targeting MDM2/MDMX PET Imaging

Early Phase 1

Not yet recruiting

• Conditions: Positron Emission Tomography Imaing; MDM2/MDMX Gene Mutation; Nuclear Medicine
• Interventions: Drug: [68Ga] MDM2/MDMX Peptide

• Registration Number: NCT06443762
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-05
• Last Update Posted: 2024-06-05
• Study Start: 2024-06-10
• Primary Completion: 2024-11-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group patients who underwent PET scanning with injection probes	[68Ga] MDM2/MDMX Peptide	\[68Ga\] MDM2/MDMX Peptide PET/CT Imaging: Patients are intravenously injected with prepared and quality-assured \[68Ga\] MDM2/MDMX Peptide (0.05-0.1 mCi/kg). Imaging is performed 40 minutes to 1 hour post-injection using either the United Imaging uEXPLORER 2m PET/CT or Siemens Biograph m-CT flow PET/CT for whole-body scans, extending from the top of the head to the feet. In cases where conventional imaging reveals indeterminate lesions, delayed imaging is conducted for further differentiation. The patient is positioned supine with calm respiration. The imaging conditions for the head and torso remain as described above. Data are reconstructed using the OSEM method to produce coronal, sagittal, and axial PET and PET/CT fusion images.

Primary Outcome Measures

Name	Time	Method
SUV	1 hour and 2 hours after drug injection	Standardized Uptake Values (SUV) of \[68Ga\] MDM2/MDMX Peptide at various time points within the imaging window for target lesions or suspected tumor lesions in subjects with solid tumors or suspected solid tumors.