CancerPhase 2NCT04023240
68-Ga-FAPI PET Imaging in Malignancy
A Phase 2 study testing 68Ga-FAPI, Computed Tomography (CT) scan and Positron Emission Tomography (PET) scan in people with Cancer, run by Stanford University at 1 site in United States.
Trial summary
This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Cancer
- What is being tested?
- 68Ga-FAPI, Computed Tomography (CT) scan and Positron Emission Tomography (PET) scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2023to 14 Dec 2023
- Phase
- Phase 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 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with current malignancy confirmed via pathology or imaging
- Patient must be > 18 years old
- Patient must be willing and able to provide written informed consent for the trial
- Patient of reproductive potential will have a pregnancy test
Who cannot join
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: 68Ga-FAPI PET Imaging in Malignancy
This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.
Read the detailed description
PRIMARY OBJECTIVE:
To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI.
OUTLINE:
Patients receive 68Ga-FAPI intravenously (IV) and then undergo PET/CT approximately 1 hour later.
After completion of study, patients are followed up at 24-72 hours.
- Conditions
- Cancer
- Being tested
- 68Ga-FAPI, Computed Tomography (CT) scan, Positron Emission Tomography (PET) scan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPIDrug
Also called 68-Ga-Fibroblast activation protein inhibitor (FAPI)
68Ga-FAPI is quinoline based PET radiopharmaceutical.
68Ga-FAPI is administered intravenously (IV)
Computed Tomography (CT) scanProcedure or surgery
Participants will have a CT scan for attenuation correction and anatomic localization of PET data.
Positron Emission Tomography (PET) scanProcedure or surgery
PET images will be acquired.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI PET/CT | Experimental | Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later. Receives: Drug: 68Ga-FAPI; Procedure: Computed Tomography (CT) scan; Procedure: Positron Emission Tomography (PET) scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of 68Ga-FAPI PET
Feasibility of 68Ga-FAPI PET/CT imaging will be done to assess patients with malignancy. Feasibility will be measured using Likert scale (1-non diagnostic; 5-excellent; anything 3 or more is diagnostic). The study will be feasible if > 50% of scans will have a score of 3 or more
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study startJul 2023 (estimated)
- Primary completion14 Jul 2023 (estimated)
- Study completion14 Dec 2023 (estimated)
Why it stopped: no patients enrolled into study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carina A Mari, MD, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023240
- Sponsor's protocol ID
- IRB-52129
- Other IDs
- VAR0195
- Status last verified
- Aug 2024
- First submitted
- 15 Jul 2019
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-FAPI PET Imaging in Malignancy
- ClinicalTrials.gov ID
- NCT04023240
- Acronym / sponsor ID
- IRB-52129
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients enrolled into study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- 14 Jul 2023 (estimated)
- Study completion
- 14 Dec 2023 (estimated)
- First posted
- 17 Jul 2019 (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 feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.
Detailed description
PRIMARY OBJECTIVE:
To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI.
OUTLINE:
Patients receive 68Ga-FAPI intravenously (IV) and then undergo PET/CT approximately 1 hour later.
After completion of study, patients are followed up at 24-72 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI PET/CT | Experimental | Drug: 68Ga-FAPI, Procedure: Computed Tomography (CT) scan, Procedure: Positron Emission Tomography (PET) scanPatients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with current malignancy confirmed via pathology or imaging
- Patient must be > 18 years old
- Patient must be willing and able to provide written informed consent for the trial
- Patient of reproductive potential will have a pregnancy test
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding
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-FAPIAlso: 68-Ga-Fibroblast activation protein inhibitor (FAPI)68Ga-FAPI is quinoline based PET radiopharmaceutical. 68Ga-FAPI is administered intravenously (IV) | Drug | 68Ga-FAPI PET/CT |
| Computed Tomography (CT) scanParticipants will have a CT scan for attenuation correction and anatomic localization of PET data. | Procedure or surgery | 68Ga-FAPI PET/CT |
| Positron Emission Tomography (PET) scanPET images will be acquired. | Procedure or surgery | 68Ga-FAPI PET/CT |
Primary outcome
Feasibility of 68Ga-FAPI PET
Time frame: 24 months
Feasibility of 68Ga-FAPI PET/CT imaging will be done to assess patients with malignancy. Feasibility will be measured using Likert scale (1-non diagnostic; 5-excellent; anything 3 or more is diagnostic). The study will be feasible if > 50% of scans will have a score of 3 or more
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- 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.
Carina A Mari, MD principal investigator
Stanford Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-FAPI, Computed Tomography (CT) scan and Positron Emission Tomography (PET) scan in people with Cancer, run by Stanford University at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 12 Aug 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 United States. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of 68Ga-FAPI PET (time frame: 24 months). 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 12 Aug 2024.