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

NCT05490849 | Unknown Early Phase 1

• 1 other identifier: XLan-0799
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Visual and standardized uptake values assessment of lesions and biodistribution

  At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of 68Ga-HX01 by the tumor, which implies a greater threat of the tumor being malignant or higher stage.

  1 year

Secondary Outcomes (7)

• Radioactivity in the blood and urine samples

  1 year

• Adverse events collection

  1 year

• Concentration of tumor markers (e.g., carcinoembryonic antigen, CA125, CA199) in participants' blood

  1 year

• Count of red blood cells, white blood cells, hemoglobin and platelets; mean corpuscular volume (MCV), hematocrit

  1 year

• Concentration of alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), albumin and total protein in participants' blood

  1 year

Study Arms (1)

68Ga-HX01 PET scanning

EXPERIMENTAL

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

Drug: 68Ga-HX01

Interventions

68Ga-HX01 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.

Also known as: gallium-68 (68Ga)-HX01

68Ga-HX01 PET scanning

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers:
• fully understand and voluntarily sign the informed consent form
• male or female, age 18-65 years
• 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)
• 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
• no abnormalities in the evaluation of vital signs and physical exam
• 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
• be able to communicate effectively with the investigator and to comprehend and adhere to the study's criteria
• Cancer patients:
• The subject or his or her legal guardian may sign the informed consent form
• a commitment to comply with the study guidelines and to to work with the investigator during the duration of the study
• 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
• pathological results to be obtained by biopsy or surgical resection

You may not qualify if:

• Healthy volunteers:
• allergic body
• acute diseases diagnosed before the study
• have undergone surgery within 6 months prior to the trial would affect the absorption, distribution, metabolism, or excretion of the drug
• have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines) within 2 weeks prior to the study
• pregnant and lactating women
• Cancer patients:
• patients or their legal guardian are unable or unwilling to sign the informed consent form
• incapacity to collaborate in the complete implementation of the study
• a history of cancer or oncologic treatment
• acute systemic diseases and electrolyte disturbances
• pregnant or lactating women

Sponsors & Collaborators

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

Study Sites (1)

China, Hubei Province

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 39976700 DERIVED

• 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.

  PMID: 39847870 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Gallium-68

Study Officials

• Xiaoli Lan, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Xiaoli Lan, PhD

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 8, 2022
• Study Start: October 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 22, 2023

Record last verified: 2022-08

Locations

CN (1)