Malignant NeoplasmNCT06206642
Comparing 18F-FAPI-04 and 18F-FDG PET/CT in Cancer Detection
A study testing PET/CT in people with Malignant Neoplasm, run by Lanzhou University Second Hospital at 1 site in China.
Trial summary
Evaluating fluoro-18-fibroblast activation protein inhibitor-04 positron emission computed tomography's diagnostic efficacy for primary malignancies versus 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years old); PET/CT examination is required after evaluation by oncologist. Healthy persons who volunteer for PET/CT scans; Can cooperate to complete the inspection process; I or family members, legal representatives agree to participate in the study and can sign the informed consent in person.
Who cannot join
- The patient has a serious underlying disease or mental illness and is unable to cooperate with the PET/CT examination; Have received systematic chemotherapy; Previous history of primary tumor; Pregnancy; I or family members, legal representatives are unable or unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Novel Targeted Molecular Probe 18F-FAPI-04 PET/CT for Various Malignant Tumors: Comparison With 18F-FDG PET/CT
Evaluating fluoro-18-fibroblast activation protein inhibitor-04 positron emission computed tomography's diagnostic efficacy for primary malignancies versus 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose.
Read the detailed description
In recent years, radionuclide labeled fibroblast activating protein inhibitors (FAPIs) have gradually become a new strategy for targeted diagnosis and therapy. In this study, radionuclide 18F was used to label FAPI, and the imaging value of FAPI was compared with that of common developer 18F-FDG. To evaluate the diagnostic value of 18F-FAPI-04 PET/CT in various malignant tumors.
- Conditions
- Malignant Neoplasm
- Being tested
- PET/CT
- Keywords
- 18F-FDG, 18F-FAPI, PET/CT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDiagnostic test
Low-dose CT images were first collected during scanning. The tube voltage was 120kilovolt, the tube current was 50-220Milliampere and the layer thickness was 3.75mm.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FAPI-04 | Experimental | 18F-FAPI-04 PET-CT is injected through the patient's elbow vein without special preparation at a dose of 2.96-5.55 megabecquerels (MBq) /kg (0.08-0.15 millicurie/kg). Receives: Diagnostic Test: PET/CT |
| 18F-FDG | Experimental | Before the 18F-FDG PET/CT examination, all patients should fast for at least 4-6 hours, and the fasting blood glucose should be controlled to less than 9.0mmol/L to avoid difficulties in image analysis due to poor blood glucose in patients. 18F-FDG is administered via the patient's elbow vein at a dose of 2.96-5.55 megabecquerels (MBq) /kg (0.08-0.15 millicurie/kg). Receives: Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 18F-FAPI-04 PET/CT
McNemar test
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Apr 2022
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lanzhou University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoxue Tian, Lanzhou University Second Hospital
- Investigators
- Liu Jiangyan, Study director, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206642
- Sponsor's protocol ID
- XTian
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Targeted Molecular Probe 18F-FAPI-04 PET/CT for Various Malignant Tumors: Comparison With 18F-FDG PET/CT
- ClinicalTrials.gov ID
- NCT06206642
- Acronym / sponsor ID
- XTian
- Conditions
- Malignant Neoplasm
- Keywords
- 18F-FDG, 18F-FAPI, PET/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Lanzhou University Second HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Jan 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.
Evaluating fluoro-18-fibroblast activation protein inhibitor-04 positron emission computed tomography's diagnostic efficacy for primary malignancies versus 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose.
Detailed description
In recent years, radionuclide labeled fibroblast activating protein inhibitors (FAPIs) have gradually become a new strategy for targeted diagnosis and therapy. In this study, radionuclide 18F was used to label FAPI, and the imaging value of FAPI was compared with that of common developer 18F-FDG. To evaluate the diagnostic value of 18F-FAPI-04 PET/CT in various malignant tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18F-FAPI-04 | Experimental | Diagnostic Test: PET/CT18F-FAPI-04 PET-CT is injected through the patient's elbow vein without special preparation at a dose of 2.96-5.55 megabecquerels (MBq) /kg (0.08-0.15 millicurie/kg). |
| 18F-FDG | Experimental | Diagnostic Test: PET/CTBefore the 18F-FDG PET/CT examination, all patients should fast for at least 4-6 hours, and the fasting blood glucose should be controlled to less than 9.0mmol/L to avoid difficulties in image analysis due to poor blood glucose in patients. 18F-FDG is administered via the patient's elbow vein at a dose of 2.96-5.55 megabecquerels (MBq) /kg (0.08-0.15 millicurie/kg). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (≥18 years old); PET/CT examination is required after evaluation by oncologist. Healthy persons who volunteer for PET/CT scans; Can cooperate to complete the inspection process; I or family members, legal representatives agree to participate in the study and can sign the informed consent in person.
Key exclusion criteria (1 listed)
- The patient has a serious underlying disease or mental illness and is unable to cooperate with the PET/CT examination; Have received systematic chemotherapy; Previous history of primary tumor; Pregnancy; I or family members, legal representatives are unable or unwilling 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 |
|---|---|---|
| PET/CTLow-dose CT images were first collected during scanning. The tube voltage was 120kilovolt, the tube current was 50-220Milliampere and the layer thickness was 3.75mm. | Diagnostic test | 18F-FAPI-04, 18F-FDG |
Primary outcome
Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 18F-FAPI-04 PET/CT
Time frame: 1 week
McNemar test
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 Jan 2024.
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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.
Liu Jiangyan study director
Lanzhou University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT in people with Malignant Neoplasm, run by Lanzhou University Second Hospital 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 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: finished, as of the sponsor's last update on 16 Jan 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.
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?
Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 18F-FAPI-04 PET/CT (time frame: 1 week). 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 16 Jan 2024.