Trial Title:
68Ga-HX01 PET in Healthy Volunteers and Malignant Tumors Patients
NCT ID:
NCT05490849
Condition:
Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-HX01
Description:
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.
Arm group label:
68Ga-HX01 PET scanning
Other name:
gallium-68 (68Ga)-HX01
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
China, Hubei Province
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoli Lan
Phone:
+86-027-83692633
Email:
lxl730724@hotmail.com
Start date:
October 1, 2021
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490849