Malignant NeoplasmAGREE-FAPINCT04990882
FAPI PET/CT Prospective Interobserver Agreement
An observational study of Malignant Neoplasm, run by University Hospital, Essen at 1 site in Germany.
Trial summary
The aim of the present study is to evaluate the interobserver agreement for FAPI PET/CT interpretations of representative cancer types and compare findings among readers with different levels of experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Interpretation of FAPI-PET/CT scans
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2021to 30 Oct 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Each recruited observer will be asked to review 50 68Ga-FAPI PET/CT scans of patients with different types of tumor. Observers will be blinded to clinical data except of the following patient information: sex, age (years), weight (Kg), injected dose (MBq), uptake time (min), type of cancer and PET/CT indication (e.g. staging, re-staging after surgery, evaluation after therapy). Each observer will be also asked to record maximum standardized uptake value (SUVmax) for one exemplary lesion for each tissue (organ, node, bone).
Who may be able to join
- Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT from high-volume centers (Essen, Germany; Bologna, Italy; Los Angeles, USA; Munich, Germany, Münster, Germany ) will be prospectively recruited as research observers. Each observer will be asked to report the number of previous clinical 68Ga-FAPI PET/CT scans and then will be classified on the basis of the experience in these three groups:
- Low experience (< 30 prior 68Ga-FAPI PET/CT studies);
- Intermediate experience (30 to 300 studies);
- High experience (> 300 studies) At least three observers will be needed for each group.
Who cannot join
- No prior PET/CT experience.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FAPI PET/CT Imaging for Cancer: A Prospective Interobserver Agreement Study
The aim of the present study is to evaluate the interobserver agreement for FAPI PET/CT interpretations of representative cancer types and compare findings among readers with different levels of experience.
Read the detailed description
Fibroblast activation protein (FAP) is expressed by many cancer-associated fibroblasts, having a pivotal role in many desmoplastic tumor histotypes (sarcoma, pancreatic cancer, colorectal cancer). 68Ga-FAPI inhibitor (FAPI) is a promising novel molecular imaging tracer for positron emission tomography with computed tomography (PET/CT), with favorable initial results in different tumor entities. Compared to 18F-FDG, 68Ga-FAPI PET/CT shows a similar biodistribution, with less background tracer uptake in the brain, oral mucosa and liver, thus making this tracer potentially suitable to detect tumor lesions in these regions.
Moreover, the FAPI ligand contains a DOTA peptide which makes it appropriate also for therapeutic options if linked with 177Lutetium or 90Yttrium.
There is an increasing number of trials aimed to assess the efficacy and the clinical impact of 68Ga-FAPI PET/CT. Therefore, the inter-observer agreement and variability with 68Ga-FAPI PET/CT need to be established.
- Conditions
- Malignant Neoplasm
- Being tested
- Interpretation of FAPI-PET/CT scans
- Keywords
- FAPI, cancer, Positron-Emission-Tomography, FAP, fibroblast, imaging, PET, Interobserver agreement
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation of FAPI-PET/CT scansOther
Each observer's Group will be asked to review FAPI-PET/CT scans of patients with representative cancer types.
| Study group | Role | What they receive |
|---|---|---|
| Low Experience Group | Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of less than 30 studies. Receives: Other: Interpretation of FAPI-PET/CT scans | |
| Intermediate Experience Group | Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of more than 30 studies and less than 300 studies. Receives: Other: Interpretation of FAPI-PET/CT scans | |
| High Experience Group | Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of more than 300 studies. Receives: Other: Interpretation of FAPI-PET/CT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement among observer groups in interpreting FAPI PET/CT scans
Number of concordant scans among observer groups. Each scan will be rated as positive, negative or suspicion. For each scan all definite and suspicious lesions will be reported as well. Observer's reports data will be compared with an Expert Reading, which includes lesion validation, if applicable (i.e. imaging, laboratory, histopathology).
Measured: 3 Months
Secondary outcomes (1)
Agreement among observer groups in interpreting TNM stage and semi-quantitative values.
Number of concordant scans for TNM staging and for semi-quantitative values among observer groups. For each scan all definite and suspicious lesions with uptake values will be reported and a post-analysis TNM staging will be performed. Observer's reports data will be compared with an Expert Reading, which includes lesion validation, if applicable (i.e. imaging, laboratory, histopathology).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Wolfgang Fendler, University Hospital, Essen
- Investigators
- Wolfgang Fendler, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990882
- Sponsor's protocol ID
- AGREE-FAPI
- Acronym
- AGREE-FAPI
- Status last verified
- Nov 2022
- First submitted
- 16 Jul 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAPI PET/CT Imaging for Cancer: A Prospective Interobserver Agreement Study
- ClinicalTrials.gov ID
- NCT04990882
- Acronym / sponsor ID
- AGREE-FAPI / AGREE-FAPI
- Conditions
- Malignant Neoplasm
- Keywords
- FAPI, cancer, Positron-Emission-Tomography, FAP, fibroblast, imaging, PET, Interobserver agreement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 5 Aug 2021 (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 aim of the present study is to evaluate the interobserver agreement for FAPI PET/CT interpretations of representative cancer types and compare findings among readers with different levels of experience.
Detailed description
Fibroblast activation protein (FAP) is expressed by many cancer-associated fibroblasts, having a pivotal role in many desmoplastic tumor histotypes (sarcoma, pancreatic cancer, colorectal cancer). 68Ga-FAPI inhibitor (FAPI) is a promising novel molecular imaging tracer for positron emission tomography with computed tomography (PET/CT), with favorable initial results in different tumor entities. Compared to 18F-FDG, 68Ga-FAPI PET/CT shows a similar biodistribution, with less background tracer uptake in the brain, oral mucosa and liver, thus making this tracer potentially suitable to detect tumor lesions in these regions.
Moreover, the FAPI ligand contains a DOTA peptide which makes it appropriate also for therapeutic options if linked with 177Lutetium or 90Yttrium.
There is an increasing number of trials aimed to assess the efficacy and the clinical impact of 68Ga-FAPI PET/CT. Therefore, the inter-observer agreement and variability with 68Ga-FAPI PET/CT need to be established.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Experience Group | – | Other: Interpretation of FAPI-PET/CT scansNuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of less than 30 studies. |
| Intermediate Experience Group | – | Other: Interpretation of FAPI-PET/CT scansNuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of more than 30 studies and less than 300 studies. |
| High Experience Group | – | Other: Interpretation of FAPI-PET/CT scansNuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of more than 300 studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each recruited observer will be asked to review 50 68Ga-FAPI PET/CT scans of patients with different types of tumor. Observers will be blinded to clinical data except of the following patient information: sex, age (years), weight (Kg), injected dose (MBq), uptake time (min), type of cancer and PET/CT indication (e.g. staging, re-staging after surgery, evaluation after therapy). Each observer will be also asked to record maximum standardized uptake value (SUVmax) for one exemplary lesion for each tissue (organ, node, bone).
Key inclusion criteria (4 listed)
- Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT from high-volume centers (Essen, Germany; Bologna, Italy; Los Angeles, USA; Munich, Germany, Münster, Germany ) will be prospectively recruited as research observers. Each observer will be asked to report the number of previous clinical 68Ga-FAPI PET/CT scans and then will be classified on the basis of the experience in these three groups:
- Low experience (< 30 prior 68Ga-FAPI PET/CT studies);
- Intermediate experience (30 to 300 studies);
- High experience (> 300 studies) At least three observers will be needed for each group.
Key exclusion criteria (1 listed)
- No prior PET/CT experience.
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 |
|---|---|---|
| Interpretation of FAPI-PET/CT scansEach observer's Group will be asked to review FAPI-PET/CT scans of patients with representative cancer types. | Other | High Experience Group, Intermediate Experience Group, Low Experience Group |
Primary outcome
Agreement among observer groups in interpreting FAPI PET/CT scans
Time frame: 3 Months
Number of concordant scans among observer groups. Each scan will be rated as positive, negative or suspicion. For each scan all definite and suspicious lesions will be reported as well. Observer's reports data will be compared with an Expert Reading, which includes lesion validation, if applicable (i.e. imaging, laboratory, histopathology).
1 secondary outcome
Agreement among observer groups in interpreting TNM stage and semi-quantitative values.
Time frame: 3 Months
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 3 Nov 2022.
- 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.
Wolfgang Fendler, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm, run by University Hospital, Essen at 1 site in Germany.
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: finished, as of the sponsor's last update on 3 Nov 2022. 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 Germany. 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?
Agreement among observer groups in interpreting FAPI PET/CT scans (time frame: 3 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 3 Nov 2022; AzTrials last refreshed its copy on 4 Nov 2026.