HealthyPhase 1NCT06416774
A Clinical Study of 68Ga-HX01 Injection for PET Imaging
A Phase 1 study testing 68Ga-HX01 Injection(0.05mCi/kg), 68Ga-HX01 Injection(0.1mCi/kg) and 68Ga-HX01 Injection(0.07mCi/kg) in people with Healthy and Malignancy, run by Hexin (Suzhou) Pharmaceutical Technology Co., Ltd at 1 site in China.
Trial summary
This is a single-center, open Phase I clinical study, consisting of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Malignancy
- What is being tested?
- 68Ga-HX01 Injection(0.05mCi/kg), 68Ga-HX01 Injection(0.1mCi/kg) and 68Ga-HX01 Injection(0.07mCi/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2022to 30 Oct 2023
- Phase
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-50 years old;
- Female weight 45-80kg, male weight 50-80kg;
- Agree to take effective contraception during the study and for at least three months after the drug administration.
- Patients with malignant solid tumors with measurable lesions (target lesions) confirmed by histopathology or cytology or clinical diagnosis;
- 18-75 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1;
- life expectancy ≥6 months;
- Agree to take effective contraception during the study and for at least three months after the drug administration.
Who cannot join
- Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration;
- Known or suspected allergic to the test drug or any of its components;
- Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment;
- Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening;
- Clinically significant abnormalities in hematology, blood biochemistry, and urine routine during screening;
- Patients with clinically significant diseases within 4 weeks before screening;
Show all 24Show fewer
- Blood pressure higher than 150/100 mmHg or lower than 90/50 mmHg at screening;
- Use of any prescription or over-the-counter drugs within 2 weeks before the trial drug administration;
- Blood donation or blood loss ≥500 mL within 12 weeks before administration;
- History of drug or alcohol abuse within 12 months prior to administration;
- Smoking more than 5 cigarettes a day or consuming the same amount of nicotine or nicotine replacement within 3 months before administration;
- History of malignancy;
- Plan to schedule surgery and other invasive interventions within one week of the test drug injection;
- Compliance to lie for about 90 minutes during the PET examination.
- Phase Ib:
- Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration;
- Known or suspected allergic to the test drug or any of its components;
- Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment;
- Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening;
- Any radiotherapeutic drugs used within 90 days before administration, or any radionuclide diagnostic drugs received within 3 days before administration;
- Plan to schedule surgery and other invasive interventions within 2 days after trial drug injection;
- Abnormal liver and kidney function: serum total bilirubin (TBIL) > 1.5×ULN (upper limit of normal), or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5×ULN, or serum creatinine > 1.5×ULN;
- With active infection at the time of screening;
- Compliance to lie for about 60 minutes during the PET examination.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging
This is a single-center, open Phase I clinical study, consisting of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors.
Read the detailed description
Phase Ia design:
The Phase Ia study is designed to evaluate the safety, biodistribution (PET imaging), radiation dose, and pharmacokinetics of 68Ga-HX01 injection after a single intravenous administration in healthy Chinese adult subjects.
Twelve healthy adult subjects will be enrolled in the Phase Ia program.
Phase Ib design:
The purpose of the Phase Ib clinical study is to evaluate the safety and biodistribution (PET imaging) of patients with malignant solid tumors receiving a single intravenous administration of 68Ga-HX01 injection, and to explore the characteristics of tumor imaging.
Ten patients with malignant solid tumors will be enrolled in Phase Ib.
- Conditions
- Healthy, Malignancy
- Being tested
- 68Ga-HX01 Injection(0.05mCi/kg), 68Ga-HX01 Injection(0.1mCi/kg), 68Ga-HX01 Injection(0.07mCi/kg)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-HX01 Injection(0.05mCi/kg)Drug
Also called 68Ga-HX01
The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring.
They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments.
68Ga-HX01 Injection(0.1mCi/kg)Drug
Also called 68Ga-HX01
The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring.
They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments.
68Ga-HX01 Injection(0.07mCi/kg)Drug
Also called 68Ga-HX01
The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for safety monitoring.
They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments.
| Study group | Role | What they receive |
|---|---|---|
| Ia: Low-dose group | Experimental | The injection dose of 68Ga-HX01 for low-dose group is 0.05 mCi/kg. Receives: Drug: 68Ga-HX01 Injection(0.05mCi/kg) |
| Ia: High-dose group. | Experimental | The injection dose of 68Ga-HX01 for the high-dose group is 0.1 mCi/kg. Receives: Drug: 68Ga-HX01 Injection(0.1mCi/kg) |
| Ib: Patients with malignancy. | Experimental | The injection dose for phase Ib patients was 0.07 mCi/ kg. Receives: Drug: 68Ga-HX01 Injection(0.07mCi/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Changes in body temperature after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on body temperature.
Measured: During the screening period (within 7 days), within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Respiration
Changes in respiration rate after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on respiration.
Measured: Time Frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Pulse
Changes in pulse after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on pulse.
Measured: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Blood pressure
Changes in diastolic pressure and systolic pressure after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on blood pressure.
Measured: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Oxygen saturation
Changes in oxygen saturation after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on oxygen saturation.
Measured: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram QT Interval
Electrocardiogram QT interval was recorded to assess the effect of 68Ga-HX01 administration.
Measured: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram QRS Interval
Electrocardiogram QRS interval was recorded to assess the effect of 68Ga-HX01 administration.
Measured: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram PR Interval
Electrocardiogram PR interval was recorded to assess the effect of 68Ga-HX01 administration.
Measured: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram T Wave
The shape of electrocardiogram T wave was recorded to assess the effect of 68Ga-HX01 administration.
Measured: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram ST Segment
The shape of electrocardiogram ST segment was recorded to assess the effect of 68Ga-HX01 administration.
Measured: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Number of Participants With Abnormal Laboratory Values in Blood routine
The blood routine of Day 2 was recorded.
Measured: Day 2.
Number of Participants With Abnormal Laboratory Values in Blood biochemistry
Blood biochemistry of Day 2 was recorded.
Measured: Day 2.
Prothrombin time test and/or a partial thromboplastin time test (PTT)
Coagulation function of Day 2 was recorded.
Measured: Day 2.
Number of Participants With Abnormal Laboratory Values in Urine routine
Urine routine of Day 2 was recorded.
Measured: Day 2.
Secondary outcomes (6)
Dosimetry
OLINDA/EXM software was used to calculate the radiation dose using the uptake of each organ and tissue in Ia subjects. The uptake values are calculated from the SUV values of PET images at each time point.
Measured: At 10, 30, 60 and 120 minutes after 68Ga-HX01 injection.
The percentage of injected dose per gram (% ID/g)
The blood radioactivity time-activity curve was drawn based on the percentage of injected dose per gram (% ID/g) of blood samples at each time point.
Measured: Blood samples are collected for the radioactivity determination before (within 30 minutes) and after 68Ga-HX01 injection at different time points (2, 5, 10, 30, 60, 90, 120, and 180 minutes).
The max uptake of each lesion
SUVmax was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.
Measured: At 30 and 60 minutes after 68Ga-HX01 injection.
The mean uptake of each lesion
SUVmean was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.
Measured: At 30 and 60 minutes after 68Ga-HX01 injection.
Lesion number
Lesion number was recorded.
Measured: At 30 and 60 minutes after 68Ga-HX01 injection.
The size of each lesion
Lesion size was recorded.
Measured: At 30 and 60 minutes after 68Ga-HX01 injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start29 Dec 2022
- Primary completion20 Jul 2023
- Study completion30 Oct 2023
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 HealthyStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hexin (Suzhou) Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416774
- Sponsor's protocol ID
- XLan-0688
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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, Fang H, Yang B, Qin C, Hu F, Ruan W, Chen J, Zeng D, Gai Y, Lan X. Phase I study of [68Ga]Ga-HX01 for targeting integrin alphavbeta3 and CD13 in healthy and malignancy subjects. Eur J Nucl Med Mol Imaging. 2025 Mar;52(4):1293-1304. doi: 10.1007/s00259-024-07002-3. Epub 2024 Nov 29.
PubMed 39609274
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging
- ClinicalTrials.gov ID
- NCT06416774
- Acronym / sponsor ID
- XLan-0688
- Conditions
- Healthy, Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hexin (Suzhou) Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 16 May 2024 (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.
This is a single-center, open Phase I clinical study, consisting of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors.
Detailed description
Phase Ia design:
The Phase Ia study is designed to evaluate the safety, biodistribution (PET imaging), radiation dose, and pharmacokinetics of 68Ga-HX01 injection after a single intravenous administration in healthy Chinese adult subjects.
Twelve healthy adult subjects will be enrolled in the Phase Ia program.
Phase Ib design:
The purpose of the Phase Ib clinical study is to evaluate the safety and biodistribution (PET imaging) of patients with malignant solid tumors receiving a single intravenous administration of 68Ga-HX01 injection, and to explore the characteristics of tumor imaging.
Ten patients with malignant solid tumors will be enrolled in Phase Ib.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ia: Low-dose group | Experimental | Drug: 68Ga-HX01 Injection(0.05mCi/kg)The injection dose of 68Ga-HX01 for low-dose group is 0.05 mCi/kg. |
| Ia: High-dose group. | Experimental | Drug: 68Ga-HX01 Injection(0.1mCi/kg)The injection dose of 68Ga-HX01 for the high-dose group is 0.1 mCi/kg. |
| Ib: Patients with malignancy. | Experimental | Drug: 68Ga-HX01 Injection(0.07mCi/kg)The injection dose for phase Ib patients was 0.07 mCi/ kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-50 years old;
- Female weight 45-80kg, male weight 50-80kg;
- Agree to take effective contraception during the study and for at least three months after the drug administration.
- Patients with malignant solid tumors with measurable lesions (target lesions) confirmed by histopathology or cytology or clinical diagnosis;
- 18-75 years old;
Key exclusion criteria (24 listed)
- Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration;
- Known or suspected allergic to the test drug or any of its components;
- Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment;
- Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening;
- Clinically significant abnormalities in hematology, blood biochemistry, and urine routine during screening;
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-HX01 Injection(0.05mCi/kg)Also: 68Ga-HX01The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments. | Drug | Ia: Low-dose group |
| 68Ga-HX01 Injection(0.1mCi/kg)Also: 68Ga-HX01The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments. | Drug | Ia: High-dose group. |
| 68Ga-HX01 Injection(0.07mCi/kg)Also: 68Ga-HX01The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments. | Drug | Ib: Patients with malignancy. |
Primary outcome
Temperature
Time frame: During the screening period (within 7 days), within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in body temperature after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on body temperature.
Respiration
Time frame: Time Frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in respiration rate after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on respiration.
Pulse
Time frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in pulse after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on pulse.
Blood pressure
Time frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in diastolic pressure and systolic pressure after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on blood pressure.
Oxygen saturation
Time frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in oxygen saturation after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on oxygen saturation.
Electrocardiogram QT Interval
Time frame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram QT interval was recorded to assess the effect of 68Ga-HX01 administration.
Electrocardiogram QRS Interval
Time frame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram QRS interval was recorded to assess the effect of 68Ga-HX01 administration.
Electrocardiogram PR Interval
Time frame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram PR interval was recorded to assess the effect of 68Ga-HX01 administration.
Electrocardiogram T Wave
Time frame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
The shape of electrocardiogram T wave was recorded to assess the effect of 68Ga-HX01 administration.
Electrocardiogram ST Segment
Time frame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
The shape of electrocardiogram ST segment was recorded to assess the effect of 68Ga-HX01 administration.
Number of Participants With Abnormal Laboratory Values in Blood routine
Time frame: Day 2.
The blood routine of Day 2 was recorded.
Number of Participants With Abnormal Laboratory Values in Blood biochemistry
Time frame: Day 2.
Blood biochemistry of Day 2 was recorded.
Prothrombin time test and/or a partial thromboplastin time test (PTT)
Time frame: Day 2.
Coagulation function of Day 2 was recorded.
Number of Participants With Abnormal Laboratory Values in Urine routine
Time frame: Day 2.
Urine routine of Day 2 was recorded.
6 secondary outcomes
Dosimetry
Time frame: At 10, 30, 60 and 120 minutes after 68Ga-HX01 injection.
The percentage of injected dose per gram (% ID/g)
Time frame: Blood samples are collected for the radioactivity determination before (within 30 minutes) and after 68Ga-HX01 injection at different time points (2, 5, 10, 30, 60, 90, 120, and 180 minutes).
The max uptake of each lesion
Time frame: At 30 and 60 minutes after 68Ga-HX01 injection.
The mean uptake of each lesion
Time frame: At 30 and 60 minutes after 68Ga-HX01 injection.
Lesion number
Time frame: At 30 and 60 minutes after 68Ga-HX01 injection.
The size of each lesion
Time frame: At 30 and 60 minutes after 68Ga-HX01 injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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 39609274Zhang X, Fang H, Yang B, Qin C, Hu F, Ruan W, Chen J, Zeng D, Gai Y, Lan X. Phase I study of [68Ga]Ga-HX01 for targeting integrin alphavbeta3 and CD13 in healthy and malignancy subjects. Eur J Nucl Med Mol Imaging. 2025 Mar;52(4):1293-1304. doi: 10.1007/s00259-024-07002-3. Epub 2024 Nov 29.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-HX01 Injection(0.05mCi/kg), 68Ga-HX01 Injection(0.1mCi/kg) and 68Ga-HX01 Injection(0.07mCi/kg) in people with Healthy and Malignancy, run by Hexin (Suzhou) Pharmaceutical Technology Co., Ltd 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 8 inclusion and 24 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: finished, as of the sponsor's last update on 16 May 2024. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: During the screening period (within 7 days), within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.). The study lists 14 primary outcomes in all. 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 NCT06416774, 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 16 May 2024.