Malignant NeoplasmEarly Phase 1NCT05490849
68Ga-HX01 PET in Healthy Volunteers and Malignant Tumors Patients
A Early Phase 1 study testing 68Ga-HX01 in people with Malignant Neoplasm, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- 68Ga-HX01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Hubei Province
Wuhan, Hubei, 430022
Xiaoli Lan, +86-027-83692633, lxl730724@hotmail.com
About this study
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.
Read the 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
- Being tested
- 68Ga-HX01
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-HX01Drug
Also called gallium-68 (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,
- Subjects should have 68Ga-HX01 and 18F-FDG PET scans two days apart.
- 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.
- Tumor biopsies or surgical specimens should be evaluated histopathologically and immunostained for biomarkers associated with angiogenesis.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-HX01 PET scanning | Experimental | Determine if 68Ga-HX01 PET is safe and effective method for imaging of malignant tumors Receives: Drug: 68Ga-HX01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (7)
Radioactivity in the blood and urine samples
Blood samples were collected at 25 minutes, 55 minutes and 115 minutes after injection of the imaging agent, and urine specimens were collected at 28 minutes, 58 minutes and 118 minutes after injection to measure the radioactivity in the blood samples and urine.
Measured: 1 year
Adverse events collection
Adverse events after the injection and scanning of healthy volunteers and patients will be followed up and assessed.
Measured: 1 year
Concentration of tumor markers (e.g., carcinoembryonic antigen, CA125, CA199) in participants' blood
Concentrations of blood tumor markers (e.g., CA125, CA199, CEA) measured on the date closest to the participant's examination will be collected. A higher blood tumor marker concentration means a higher threat or stage of tumor malignancy.
Measured: 1 year
Count of red blood cells, white blood cells, hemoglobin and platelets; mean corpuscular volume (MCV), hematocrit
Count of red blood cells, white blood cells, hemoglobin and platelets; mean corpuscular volume (MCV), hematocrit measured on the date closest to the participant's examination will be collected. Abnormal changes (increase or decrease) in the above indicators may imply that the patient is threatened by the disease, which needs to be evaluated in conjunction with the patient's medical history and clinical manifestations.
Measured: 1 year
Concentration of alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), albumin and total protein in participants' blood
Concentrations of blood alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), albumin and total protein measured on the date closest to the participant's examination will be collected. Higher concentrations of the above indicators mean that the patient's liver function is more impaired.
Measured: 1 year
Glomerular filtration rate (GFR)
This test is a measure of how well the kidneys are removing wastes and excess fluid from the blood. It is calculated from the serum creatinine level using age and gender. As kidney function decreases, the GFR level decreases.
Measured: 1 year
Blood Urea Nitrogen (BUN)
As kidney function decreases, the BUN level rises.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Oct 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoli Lan, PhD, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490849
- Sponsor's protocol ID
- XLan-0799
- Status last verified
- Aug 2022
- First submitted
- 20 Jul 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39976700Zhang 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.
PubMed 39847870
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-HX01 PET in Healthy Volunteers and Malignant Tumors Patients
- ClinicalTrials.gov ID
- NCT05490849
- Acronym / sponsor ID
- XLan-0799
- Conditions
- Malignant Neoplasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-HX01 PET scanning | Experimental | Drug: 68Ga-HX01Determine if 68Ga-HX01 PET is safe and effective method for imaging of malignant tumors |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-HX01Also: gallium-68 (68Ga)-HX01For 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. | Drug | 68Ga-HX01 PET scanning |
Primary outcome
Visual and standardized uptake values assessment of lesions and biodistribution
Time frame: 1 year
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.
7 secondary outcomes
Radioactivity in the blood and urine samples
Time frame: 1 year
Adverse events collection
Time frame: 1 year
Concentration of tumor markers (e.g., carcinoembryonic antigen, CA125, CA199) in participants' blood
Time frame: 1 year
Count of red blood cells, white blood cells, hemoglobin and platelets; mean corpuscular volume (MCV), hematocrit
Time frame: 1 year
Concentration of alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), albumin and total protein in participants' blood
Time frame: 1 year
Glomerular filtration rate (GFR)
Time frame: 1 year
Blood Urea Nitrogen (BUN)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Derived from this study: PubMed 39976700Zhang 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.
- Derived from this study: PubMed 39847870Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoli Lan, PhD study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-HX01 in people with Malignant Neoplasm, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Lan, PhD (0086-027-83692633, lxl730724@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual and standardized uptake values assessment of lesions and biodistribution (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490849, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.