NCT05490849

68Ga-HX01 PET in Healthy Volunteers and Malignant Tumors Patients

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Angiogenesis is essential in tumor growth, proliferation, progression, and metastasis. Overexpression of aminopeptidase N (APN/CD13) and/or integrin αvβ3 in endothelial and tumor cells is an essential marker of tumor-associated angiogenesis. It is highly expressed in malignant tissues such as ovarian and pancreatic cancer but less expressed in normal tissues. Therefore, CD13 and αvβ3 are important targets for diagnosis and efficacy assessment in ovarian and pancreatic cancer. Single receptor targeting probes have many disadvantages, such as relatively low binding affinity, short tumor retention time, and low tumor uptake. RGD (Arg-Gly-Asp) and NGR (Asp-Gly-Arg) are recognized peptide sequences targeting CD13 or αvβ3. PET imaging with 68Ga-HX01, a radionuclide 68Ga labeled peptide isomer formed from RGD and NGR, can be helpful for targeted diagnosis and efficacy assessment of malignant tumors. This project proposes to use 68Ga-HX01 PET imaging in the diagnosis and staging of malignant tumors, i.e., ovarian and pancreatic cancer, and to compare the diagnostic efficacy of 68Ga-HX01 with the pathology gold standard. And this study was conducted to compensate for the lack of value of 18F-FDG PET imaging for the diagnosis and staging of malignant tumors by comparing 68Ga-HX01 with the commonly used 18F-FDG PET imaging.

Detailed description

Malignant tumors are a prevalent cause of death in human diseases that pose a grave threat to human health. The prognosis can be considerably improved by early diagnosis and therapy. Nevertheless, the pathophysiology of various types of tumors varies, and the diagnosis and treatment of tumors continue to provide challenges. Angiogenesis is essential in tumor growth, proliferation, progression, and metastasis. Overexpression of aminopeptidase N (APN/CD13) and/or integrin αvβ3 in endothelial and tumor cells is an essential marker of tumor-associated angiogenesis. It is highly expressed in malignant tissues such as ovarian and pancreatic cancer but less expressed in normal tissues. Therefore, CD13 and αvβ3 are important targets for diagnosis and efficacy assessment in ovarian and pancreatic cancer. Single receptor targeting probes have many disadvantages, such as relatively low binding affinity, short tumor retention time, and low tumor uptake. RGD (Arg-Gly-Asp) and NGR (Asp-Gly-Arg) are recognized peptide sequences targeting CD13 or αvβ3. PET imaging with 68Ga-HX01, a radionuclide 68Ga labeled peptide isomer formed from RGD and NGR, can be helpful for targeted diagnosis and efficacy assessment of malignant tumors. This project proposes to use 68Ga-HX01 PET imaging in the diagnosis and staging of malignant tumors, i.e., ovarian and pancreatic cancer, and to compare the diagnostic efficacy of 68Ga-HX01 with the pathology gold standard. And this study was conducted to compensate for the lack of value of 18F-FDG PET imaging for the diagnosis and staging of malignant tumors by comparing 68Ga-HX01 with the commonly used 18F-FDG PET imaging.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	68Ga-HX01	For pharmacokinetics, healthy volunteer underwent 68Ga-HX01 PET imaging. Blood samples were collected at 25 min, 55 min, and 115 min after imaging agent injection, and urine specimens were collected at 28 min, 58 min, and 118 min after injection to measure radioactivity in blood and urine. PET/MR scans were performed at 30-50 min, 60-80 min, and 120-140 min after injection to understand absorption, distribution, and metabolism. Cancer patients, 1. Subjects should have 68Ga-HX01 and 18F-FDG PET scans two days apart. 2. Blood tests, liver and kidney function, tumor markers (CA125, CA199, CEA, etc.), and other biochemical markers must be performed one week prior to and after imaging. 3. Tumor biopsies or surgical specimens should be evaluated histopathologically and immunostained for biomarkers associated with angiogenesis.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2022-08-08
• Last updated: 2023-02-22

Locations

1 site across 1 country: China