TumorPhase 1/2NCT05506566
68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
A Phase 1/2 study testing 68Ga-FAP-CHX in people with Tumor and Positron-Emission Tomography, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor, Positron-Emission Tomography
- What is being tested?
- 68Ga-FAP-CHX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2025
- Phase
- Phase 1/2
- 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 years < Age < 75 years
- Various solid tumors with available histopathological findings, and have not been treated surgically.
- Signed informed consent.
Who cannot join
- patients with pregnancy
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Weibing Miao, MD, 059187981618, miaoweibing@126.com
Jie Zang, MD, 15901495106, 15901495106@163.com
About this study
As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.
Read the detailed description
Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. 68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a head-to-head comparison with 68Ga-FAPI-04 or 18F-FDG PET/CT scans in patients with various cancers.
- Conditions
- Tumor, Positron-Emission Tomography
- Being tested
- 68Ga-FAP-CHX
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAP-CHXDrug
The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging
68Ga-FAP-CHXDrug
Also called 68Ga-FAPI-04, 18F-FDG
68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging； 68Ga-FAPI-04, the dose will be 1.8 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging； 18F-FDG, the dose will be 3.7 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging；
| Study group | Role | What they receive |
|---|---|---|
| Part I: safety, tolerability, biodistribution and dosimetry | Experimental | PET imaging will begin at 30s (30s/bed), 15min (1 min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection, and whole-body low-dose CT needed to be re-acquired at 120 minutes Receives: Drug: 68Ga-FAP-CHX |
| Part II: diagnostic efficacy | Experimental | Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-CHX and another agent (68Ga-FAPI-04 or 18F-FDG). Receives: Drug: 68Ga-FAP-CHX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human biodistribution
reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)
Measured: From right after tracer injection to 2-hours post-injection
Human dosimetry
radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the OLINDA software.
Measured: From right after tracer injection to 2-hours post-injection
Standard uptake value (SUV)
Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
Measured: Up to 2 weeks
Lesion numbers
Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
Measured: Up to 2weeks
the sensitivity of 68Ga-FAP-CHX PET/CT
compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated.
Measured: Up to 2 weeks
the specificity of 68Ga-FAP-CHX PET/CT
compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated.
Measured: Up to 2 weeks
the accuracy of 68Ga-FAP-CHX PET/CT
compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated.
Measured: Up to 2 weeks
Secondary outcomes (2)
Count of participants with treatment emergent adverse events
The frequency and severity of treatment emergent adverse events following 68Ga-FAP-CHX injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: Up to 3 days
Expression ability of 68Ga-FAP-CHX in different types of tumors
Differentiation of SUVmax in different tumors
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 May 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
- Investigators
- Weibing Miao, MD, Study chair, The First Affiliated Hospital, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506566
- Sponsor's protocol ID
- FirstAHFujian-FAP-CHX
- Status last verified
- Sep 2023
- First submitted
- 14 Aug 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
- ClinicalTrials.gov ID
- NCT05506566
- Acronym / sponsor ID
- FirstAHFujian-FAP-CHX
- Conditions
- Tumor, Positron-Emission Tomography
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 18 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.
As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.
Detailed description
Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. 68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a head-to-head comparison with 68Ga-FAPI-04 or 18F-FDG PET/CT scans in patients with various cancers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part I: safety, tolerability, biodistribution and dosimetry | Experimental | Drug: 68Ga-FAP-CHXPET imaging will begin at 30s (30s/bed), 15min (1 min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection, and whole-body low-dose CT needed to be re-acquired at 120 minutes |
| Part II: diagnostic efficacy | Experimental | Drug: 68Ga-FAP-CHXParticipants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-CHX and another agent (68Ga-FAPI-04 or 18F-FDG). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years < Age < 75 years
- Various solid tumors with available histopathological findings, and have not been treated surgically.
- Signed informed consent.
Key exclusion criteria (2 listed)
- patients with pregnancy
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
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-FAP-CHXThe dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging | Drug | Part I: safety, tolerability, biodistribution and dosimetry |
| 68Ga-FAP-CHXAlso: 68Ga-FAPI-04, 18F-FDG68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging； 68Ga-FAPI-04, the dose will be 1.8 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging； 18F-FDG, the dose will be 3.7 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging； | Drug | Part II: diagnostic efficacy |
Primary outcome
Human biodistribution
Time frame: From right after tracer injection to 2-hours post-injection
reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)
Human dosimetry
Time frame: From right after tracer injection to 2-hours post-injection
radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the OLINDA software.
Standard uptake value (SUV)
Time frame: Up to 2 weeks
Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
Lesion numbers
Time frame: Up to 2weeks
Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
the sensitivity of 68Ga-FAP-CHX PET/CT
Time frame: Up to 2 weeks
compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated.
the specificity of 68Ga-FAP-CHX PET/CT
Time frame: Up to 2 weeks
compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated.
the accuracy of 68Ga-FAP-CHX PET/CT
Time frame: Up to 2 weeks
compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated.
2 secondary outcomes
Count of participants with treatment emergent adverse events
Time frame: Up to 3 days
Expression ability of 68Ga-FAP-CHX in different types of tumors
Time frame: Up to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Weibing Miao, MD study chair
The First Affiliated Hospital, Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-FAP-CHX in people with Tumor and Positron-Emission Tomography, run by First Affiliated Hospital of Fujian Medical University 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 3 inclusion and 2 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 21 Sep 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Weibing Miao, MD (86-0591-87981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human biodistribution (time frame: From right after tracer injection to 2-hours post-injection). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2023.