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

NCT ID: NCT05490849

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-HX01 PET scanning

Determine if 68Ga-HX01 PET is safe and effective method for imaging of malignant tumors

Group Type: EXPERIMENTAL

68Ga-HX01

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

gallium-68 (68Ga)-HX01

Eligibility Criteria

Inclusion Criteria

Healthy volunteers:

1. fully understand and voluntarily sign the informed consent form

2. male or female, age 18-65 years

3. body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women; body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including threshold values)

4. no history of chronic or severe disorders of the cardiovascular, liver, kidney, pulmonary, blood and lymphatic, endocrine, immunological, mental, neuromuscular, or gastrointestinal systems over the past three years; and good general health

5. no abnormalities in the evaluation of vital signs and physical exam

6. have no intention of having children, use effective contraception freely, and have no intention of donating sperm or eggs during the experiment and for six months following the trial's completion

7. be able to communicate effectively with the investigator and to comprehend and adhere to the study's criteria

Cancer patients:

1. The subject or his or her legal guardian may sign the informed consent form

2. a commitment to comply with the study guidelines and to to work with the investigator during the duration of the study

3. patients with clinically suspected or confirmed, but not tumor-related, ovarian cancer, pancreatic cancer, or other malignancies (supporting evidence includes serum relevant tumor markers, imaging data such as ultrasound, CT, MRI, and histological pathological examination) and in good general health

4. pathological results to be obtained by biopsy or surgical resection

Exclusion Criteria

Healthy volunteers:

1. allergic body

2. acute diseases diagnosed before the study

3. have undergone surgery within 6 months prior to the trial would affect the absorption, distribution, metabolism, or excretion of the drug

4. have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines) within 2 weeks prior to the study

5. pregnant and lactating women

Cancer patients:

1. patients or their legal guardian are unable or unwilling to sign the informed consent form

2. incapacity to collaborate in the complete implementation of the study

3. a history of cancer or oncologic treatment

4. acute systemic diseases and electrolyte disturbances

5. pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoli Lan, PhD

Role: STUDY_DIRECTOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

China, Hubei Province

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoli Lan, PhD

Role: CONTACT

lxl730724@hotmail.com

0086-027-83692633

Facility Contacts

Xiaoli Lan

Role: primary

lxl730724@hotmail.com

+86-027-83692633

References

Zhang X, Gai Y, Ye T, Fan L, Xiu L, Ruan W, Hu F, Chen J, Lan X. Head-to-head evaluation of [18F]FDG PET/CT and [68Ga]Ga-HX01 PET/MR in sarcoma patients. Eur J Nucl Med Mol Imaging. 2025 Jul;52(8):2898-2905. doi: 10.1007/s00259-025-07130-4. Epub 2025 Feb 20.

Reference Type: DERIVED

PMID: 39976700 (View on PubMed)

Zhang X, Yang B, Qin C, Song X, Lv X, Zeng D, Gai Y, Lan X. Clinical Translation of a Dual-Integrin alphavbeta3- and CD13-Targeting PET Tracer. Clin Nucl Med. 2025 Apr 1;50(4):332-337. doi: 10.1097/RLU.0000000000005647. Epub 2025 Jan 20.

Reference Type: DERIVED

PMID: 39847870 (View on PubMed)

Other Identifiers

XLan-0799

Identifier Type: -

Identifier Source: org_study_id