99mTc-FAPI-positive Gastrointestinal TumorNCT05444686
Comparative Study of 99mTc-FAPI SPECT/CT and 68Ga-FAPI PET/CT
A study testing 99mTc-FAPI in people with 99mTc-FAPI-positive Gastrointestinal Tumor, run by Xijing Hospital.
Trial summary
The purpose of this study is to compare the similarities and differences of 99mTc-FAPI quantitative SPECT/CT and 68Ga-FAPI PET/CT in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mTc-FAPI quantitative SPECT/CT for the gastrointestinal tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- 99mTc-FAPI-positive Gastrointestinal Tumor
- What is being tested?
- 99mTc-FAPI
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Jul 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with gastrointestinal tumors: diagnosed by pathological needle biopsy
Who cannot join
- refuse or cannot endure surgery pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study of 99mTc-FAPI Quantitative SPECT/CT and 68Ga-FAPI PET/CT in Clinical Diagnosis and Staging of Gastrointestinal Tumors
The purpose of this study is to compare the similarities and differences of 99mTc-FAPI quantitative SPECT/CT and 68Ga-FAPI PET/CT in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mTc-FAPI quantitative SPECT/CT for the gastrointestinal tumors.
Read the detailed description
5 healthy volunteers with whole body 99mTc-FAPI quantitative SPECT/CT scans at 1, 2, 4, 6 and 24 hours after tracer injection (mean dose, 20.0 ± 2.0 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 2, 4, 6 and 24 hours after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.
Forty patients with confirmed or suspected gastrointestinal tumors, whole body 99mTc-FAPI quantitative SPECT/CT scans will be performed on the first day, and whole body 68Ga-FAPI PET/CT scans will be performed on the next day.According to the scans results of the two agents, with SUVmax and SUVmean as the analysis indicators, the number and uptake difference of primary tumor and metastatic lesions will be compared and analyzed.
- Being tested
- 99mTc-FAPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-FAPIDiagnostic test
inject the tracer to subjects and perform SPECT/CT scans
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV of primary and metastases lesions
The standardized uptake values (SUV) in deferent organs and lesions
Measured: 2 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (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 99mTc-FAPI-positive Gastrointestinal TumorStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444686
- Sponsor's protocol ID
- KY20222134-C
- Status last verified
- Jun 2022
- First submitted
- 26 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou C, Li G, Quan Z, Deng Z, Li G, Zhang M, Kang F, Yang W, Wang J. Prospective Study Comparing [99mTc]Tc-DP-FAPI Quantitative SPECT/CT with [68Ga]Ga-FAPI-04 PET/CT in Patients with Gastrointestinal Tumors. Mol Pharm. 2024 Oct 7;21(10):5297-5304. doi: 10.1021/acs.molpharmaceut.4c00783. Epub 2024 Sep 19.
PubMed 39298637Ruan Q, Zhou C, Wang Q, Kang F, Jiang Y, Li G, Feng J, Zong S, Zhang J, Wang J. A Simple Kit Formulation for Preparation and Exploratory Human Studies of a Novel 99mTc-Labeled Fibroblast Activation Protein Inhibitor Tracer for Imaging of the Fibroblast Activation Protein in Cancers. Mol Pharm. 2023 Jun 5;20(6):2942-2950. doi: 10.1021/acs.molpharmaceut.2c01094. Epub 2023 Apr 21.
PubMed 37083360
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 99mTc-FAPI Quantitative SPECT/CT and 68Ga-FAPI PET/CT in Clinical Diagnosis and Staging of Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT05444686
- Acronym / sponsor ID
- KY20222134-C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 6 Jul 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.
The purpose of this study is to compare the similarities and differences of 99mTc-FAPI quantitative SPECT/CT and 68Ga-FAPI PET/CT in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mTc-FAPI quantitative SPECT/CT for the gastrointestinal tumors.
Detailed description
5 healthy volunteers with whole body 99mTc-FAPI quantitative SPECT/CT scans at 1, 2, 4, 6 and 24 hours after tracer injection (mean dose, 20.0 ± 2.0 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 2, 4, 6 and 24 hours after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.
Forty patients with confirmed or suspected gastrointestinal tumors, whole body 99mTc-FAPI quantitative SPECT/CT scans will be performed on the first day, and whole body 68Ga-FAPI PET/CT scans will be performed on the next day.According to the scans results of the two agents, with SUVmax and SUVmean as the analysis indicators, the number and uptake difference of primary tumor and metastatic lesions will be compared and analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with gastrointestinal tumors: diagnosed by pathological needle biopsy
Key exclusion criteria (1 listed)
- refuse or cannot endure surgery pregnant 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 |
|---|---|---|
| 99mTc-FAPIinject the tracer to subjects and perform SPECT/CT scans | Diagnostic test | – |
Primary outcome
SUV of primary and metastases lesions
Time frame: 2 hours after injection
The standardized uptake values (SUV) in deferent organs and lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 39298637Zhou C, Li G, Quan Z, Deng Z, Li G, Zhang M, Kang F, Yang W, Wang J. Prospective Study Comparing [99mTc]Tc-DP-FAPI Quantitative SPECT/CT with [68Ga]Ga-FAPI-04 PET/CT in Patients with Gastrointestinal Tumors. Mol Pharm. 2024 Oct 7;21(10):5297-5304. doi: 10.1021/acs.molpharmaceut.4c00783. Epub 2024 Sep 19.
- Derived from this study: PubMed 37083360Ruan Q, Zhou C, Wang Q, Kang F, Jiang Y, Li G, Feng J, Zong S, Zhang J, Wang J. A Simple Kit Formulation for Preparation and Exploratory Human Studies of a Novel 99mTc-Labeled Fibroblast Activation Protein Inhibitor Tracer for Imaging of the Fibroblast Activation Protein in Cancers. Mol Pharm. 2023 Jun 5;20(6):2942-2950. doi: 10.1021/acs.molpharmaceut.2c01094. Epub 2023 Apr 21.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-FAPI in people with 99mTc-FAPI-positive Gastrointestinal Tumor, run by Xijing Hospital.
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 1 inclusion and 1 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 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Jing Wang, M.D, Ph.D (86-29-84775449, wangjing@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV of primary and metastases lesions (time frame: 2 hours after injection). 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 NCT05444686, 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 6 Jul 2022.