CancerDynamic PET/CTNCT06424873
Dynamic Whole-body PET/CT Imaging in Clinical Oncology
A study testing PET/CT with FDG or FES in people with Cancer, run by Valentina Garibotto at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times in patient with oncologic pathology . The main question[s] it aims to answer are: [question 1] [question 2] Participants will [describe the main tasks participants will be asked to do… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PET/CT with FDG or FES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2024to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients clinically indicated for whole-body PET evaluation.
- Patient must agree to lie still in the camera.
- Patient must be able to comply with study procedures.
- Patient must be able to provide informed consent.
Who cannot join
- Patients < 18 years of age.
- Pregnant women are excluded.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1205
Valentina Garibotto, valentina.garibotto@hcuge.ch
About this study
The goal of this clinical trial is to to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times in patient with oncologic pathology .
The main question[s] it aims to answer are:
- [question 1]
- [question 2] Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].
Read the detailed description
Whole body hybrid PET/CT imaging, making use of the standardized uptake value (SUV), is well established in clinical setting for diagnosis and staging, treatment response monitoring and radiation therapy treatment planning of a wide range of oncologic malignancies. However, the SUV metric derived from static PET data does not capture the dynamics of the PET probe biodistribution in the body.
The present work proposes to fill in this notable gap: namely to merge whole-body and dynamic PET/CT imaging, to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times. Our proposed approach has the potential to significantly enhance diagnostic, prognostic and treatment response monitoring capabilities of PET/CT and to fundamentally alter routine clinical practice.
- Conditions
- Cancer
- Being tested
- PET/CT with FDG or FES
- 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 with FDG or FESRadiation
The study consists of an additional 50 minutes of imaging during the radiotracer's uptake phase prior to their clinical scan (standard of care).
| Study group | Role | What they receive |
|---|---|---|
| One arm study | Experimental | Additionnal images during PET/CT Receives: Radiation: PET/CT with FDG or FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard SUV measurement metric
The standard SUV measurement metric will be compared with the measured influx rate Ki as obtained from dynamic PET/CT imaging for FDG-avid processes. We expect a correlation coefficient of at least 0.8.
Measured: through study completion , an average of 2 years
Secondary outcomes (2)
Image quality
This will be assessed by clinical PET/CT readers, on a 5 point scale.
Measured: through study completion , an average of 2 years
Certainty in diagnosis of FDG-avid processes
This will be assessed by clinical PET/CT readers, on a 5 point scale.
Measured: through study completion , an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- 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
- Model description
- PET/CT
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valentina Garibotto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Valentina Garibotto, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424873
- Sponsor's protocol ID
- 2023-02102
- Other IDs
- 2023
- Acronym
- Dynamic PET/CT
- Status last verified
- May 2024
- First submitted
- 9 Nov 2023
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Whole-body PET/CT Imaging in Clinical Oncology
- ClinicalTrials.gov ID
- NCT06424873
- Acronym / sponsor ID
- Dynamic PET/CT / 2023-02102
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Valentina GaribottoUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 May 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.
The goal of this clinical trial is to to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times in patient with oncologic pathology .
The main question[s] it aims to answer are:
- [question 1]
- [question 2] Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].
Detailed description
Whole body hybrid PET/CT imaging, making use of the standardized uptake value (SUV), is well established in clinical setting for diagnosis and staging, treatment response monitoring and radiation therapy treatment planning of a wide range of oncologic malignancies. However, the SUV metric derived from static PET data does not capture the dynamics of the PET probe biodistribution in the body.
The present work proposes to fill in this notable gap: namely to merge whole-body and dynamic PET/CT imaging, to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times. Our proposed approach has the potential to significantly enhance diagnostic, prognostic and treatment response monitoring capabilities of PET/CT and to fundamentally alter routine clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PET/CT
| Arm | Type | Receives |
|---|---|---|
| One arm study | Experimental | Radiation: PET/CT with FDG or FESAdditionnal images during PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients clinically indicated for whole-body PET evaluation.
- Patient must agree to lie still in the camera.
- Patient must be able to comply with study procedures.
- Patient must be able to provide informed consent.
Key exclusion criteria (2 listed)
- Patients < 18 years of age.
- Pregnant women are excluded.
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 with FDG or FESThe study consists of an additional 50 minutes of imaging during the radiotracer's uptake phase prior to their clinical scan (standard of care). | Radiation | One arm study |
Primary outcome
Standard SUV measurement metric
Time frame: through study completion , an average of 2 years
The standard SUV measurement metric will be compared with the measured influx rate Ki as obtained from dynamic PET/CT imaging for FDG-avid processes. We expect a correlation coefficient of at least 0.8.
2 secondary outcomes
Image quality
Time frame: through study completion , an average of 2 years
Certainty in diagnosis of FDG-avid processes
Time frame: through study completion , an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
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 with FDG or FES in people with Cancer, run by Valentina Garibotto at 1 site in Switzerland.
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 2 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 22 May 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina Garibotto, Pr (+41223727252, valentina.garibotto@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard SUV measurement metric (time frame: through study completion , an average of 2 years). 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 22 May 2024.