Clinical trial NCT05490849: 68Ga-HX01 PET in Healthy Volunteers and Malignant Tumors Patients
Official title: 68Ga-HX01 PET in Healthy Volunteers and Malignant Tumors Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Visual and standardized uptake values assessment of lesions and biodistribution
timeFrame: 1 year
Secondary outcomes:
measure: Radioactivity in the blood and urine samples
timeFrame: 1 year
measure: Adverse events collection
timeFrame: 1 year
measure: Concentration of tumor markers (e.g., carcinoembryonic antigen, CA125, CA199) in participants' blood
timeFrame: 1 year
measure: Count of red blood cells, white blood cells, hemoglobin and platelets; mean corpuscular volume (MCV), hematocrit
timeFrame: 1 year
measure: Concentration of alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), albumin and total protein in participants' blood
timeFrame: 1 year
measure: Glomerular filtration rate (GFR)
timeFrame: 1 year
measure: Blood Urea Nitrogen (BUN)
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: China, Hubei Province
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaoli Lan, PhD
role: STUDY_DIRECTOR
References: