NeoplasmsNCT05442151
Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
A study testing PET/CT ([F-18]FAPI-74) in people with Neoplasms, run by Tadashi Watabe at 1 site in Japan.
Trial summary
PET / CT examination using [18F] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms
- What is being tested?
- PET/CT ([F-18]FAPI-74)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- 9 May 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who meet any of the following conditions.
- Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.
- Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.
- Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor
Who cannot join
- Pregnant women or patients who may be pregnant
- Pediatric patients requiring sedation
- Those who are judged to be inappropriate as subjects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Osaka University Hospital
Suita, Osaka, 565-0871
Tadashi Watabe, M.D., Ph.D., +81-6-6879-3461, watabe@tracer.med.osaka-u.ac.jp
Tadashi Watabe, M.D., Ph.D.
About this study
PET / CT examination using [18F] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging.
Read the detailed description
Cancer stroma accounts for more than 90% of all tumors, and cancer-related fibroblasts (CAFs) play an important role in the growth and progression of cancer. FAP expressed in CAF has been found to be expressed in many cancers, and [68Ga] FAPI-04 and [18F] FAPI-74, which are PET diagnostic agents for FAP ligand FAPI, have been used all over the world. The purpose of this study is to perform PET / CT using [18F] FAPI-74 injection for patients diagnosed with malignant tumors, mainly pancreatic cancer and gastric cancer to evaluate the pathology in detail by comparing with the FDG-PET/CT.
- Conditions
- Neoplasms
- Being tested
- PET/CT ([F-18]FAPI-74)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT ([F-18]FAPI-74)Drug
PET/CT using [18F] FAPI-74 injection
| Study group | Role | What they receive |
|---|---|---|
| FAPI-PET/CT group | Other | Not described Receives: Drug: PET/CT ([F-18]FAPI-74) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the uptake on FAPI-PET with conventional imaging
Comparison of SUV (standardized uptake value) of primary site and metastatic lesions between FAPI-PET and FDG-PET
Measured: Within 2 hours after administration of [F-18]FAPI-74 injection
Comparison with pathological specimens
Comparison of expression level (staining score) in FAP immunostaining and SUV in FAPI-PET (FAP staining is graded by scoring evaluation: high expression (3 points), moderate expression (2 points), mild expression (1 point), and no significant expression (0 point).)
Measured: Within one month after FAPI-PET
Time course of uptake on FAPI-PET
Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging
Measured: Approximately 6 months after initial FAPI-PET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start9 May 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tadashi Watabe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tadashi Watabe, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442151
- Sponsor's protocol ID
- 21472
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Naka S, Watabe T, Lindner T, Cardinale J, Kurimoto K, Moore M, Tatsumi M, Mori Y, Shimosegawa E, Valla F Jr, Kato H, Giesel FL. One-pot and one-step automated radio-synthesis of [18F]AlF-FAPI-74 using a multi purpose synthesizer: a proof-of-concept experiment. EJNMMI Radiopharm Chem. 2021 Aug 21;6(1):28. doi: 10.1186/s41181-021-00142-z.
PubMed 34420105
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
- ClinicalTrials.gov ID
- NCT05442151
- Acronym / sponsor ID
- 21472
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tadashi WatabeUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 1 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.
PET / CT examination using [18F] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging.
Detailed description
Cancer stroma accounts for more than 90% of all tumors, and cancer-related fibroblasts (CAFs) play an important role in the growth and progression of cancer. FAP expressed in CAF has been found to be expressed in many cancers, and [68Ga] FAPI-04 and [18F] FAPI-74, which are PET diagnostic agents for FAP ligand FAPI, have been used all over the world. The purpose of this study is to perform PET / CT using [18F] FAPI-74 injection for patients diagnosed with malignant tumors, mainly pancreatic cancer and gastric cancer to evaluate the pathology in detail by comparing with the FDG-PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAPI-PET/CT group | Other | Drug: PET/CT ([F-18]FAPI-74) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet any of the following conditions.
- Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.
- Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.
- Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor
Key exclusion criteria (3 listed)
- Pregnant women or patients who may be pregnant
- Pediatric patients requiring sedation
- Those who are judged to be inappropriate as subjects.
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/CT ([F-18]FAPI-74)PET/CT using [18F] FAPI-74 injection | Drug | FAPI-PET/CT group |
Primary outcome
Comparison of the uptake on FAPI-PET with conventional imaging
Time frame: Within 2 hours after administration of [F-18]FAPI-74 injection
Comparison of SUV (standardized uptake value) of primary site and metastatic lesions between FAPI-PET and FDG-PET
Comparison with pathological specimens
Time frame: Within one month after FAPI-PET
Comparison of expression level (staining score) in FAP immunostaining and SUV in FAPI-PET (FAP staining is graded by scoring evaluation: high expression (3 points), moderate expression (2 points), mild expression (1 point), and no significant expression (0 point).)
Time course of uptake on FAPI-PET
Time frame: Approximately 6 months after initial FAPI-PET
Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Results publication: PubMed 34420105Naka S, Watabe T, Lindner T, Cardinale J, Kurimoto K, Moore M, Tatsumi M, Mori Y, Shimosegawa E, Valla F Jr, Kato H, Giesel FL. One-pot and one-step automated radio-synthesis of [18F]AlF-FAPI-74 using a multi purpose synthesizer: a proof-of-concept experiment. EJNMMI Radiopharm Chem. 2021 Aug 21;6(1):28. doi: 10.1186/s41181-021-00142-z.
- Individual participant dataSharing planned: Undecided
Related trials for Neoplasms
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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.
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 ([F-18]FAPI-74) in people with Neoplasms, run by Tadashi Watabe at 1 site in Japan.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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 Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tadashi Watabe, M.D., Ph.D. (+81-6-6879-3461, watabe@tracer.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the uptake on FAPI-PET with conventional imaging (time frame: Within 2 hours after administration of [F-18]FAPI-74 injection). The study lists 3 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 NCT05442151, which also lists 1 linked publication.
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 31 Jul 2025.