Lung CancerPhase 4NCT05463913
Lung Nodule Detection Using Ultra-long FOV PET/CT
A Phase 4 study testing 18F-FDG and PET/CT imaging in people with Lung Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Indeterminate lung nodules (6-15mm) are frequent findings in patients undergoing chest CT scanning, but adequate follow-up imaging is currently not in place to facilitate early detection, diagnosis and decision making regarding treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 18F-FDG and PET/CT imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2022to 1 Jun 2025
- Phase
- Phase 4
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to give informed consent
- signed informed consent
- confirmed indeterminate lung nodule(s) of 6-15 mm in size on CT chest imaging
- routine 18F-FDG PET/CT performed
- scheduled for biopsy or resection of the lung nodules
Who cannot join
- claustrophobia
- pregnant or breastfeeding
- interval of at least 2 weeks between PET scan and last date of systemic anti-cancer therapy to reduce false-negative uptake in lesions
- radiation therapy of the target lung nodule(s)
- uncontrolled diabetes mellitus
- any medical condition potentially hampering conduction of the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Adrienne H Brouwers, MD, +31625650037, a.h.brouwers@umcg.nl
Joyce van Sluis, MSc., +31653464058, j.van.sluis@umcg.nl
About this study
Official title: Ultra-long Field-Of-View Positron Emission Tomography for Characterization of Indeterminate Lung Nodules: a Pilot Study Exploring Opportunities for Clinical Research
Indeterminate lung nodules (6-15mm) are frequent findings in patients undergoing chest CT scanning, but adequate follow-up imaging is currently not in place to facilitate early detection, diagnosis and decision making regarding treatment.
The introduction of long Field-Of-View PET/CT scanners could make a difference in this matter due to the substantial increase in sensitivity allowing optimal image quality. Whether this new technology could provide improved detection and follow-up of indeterminate lung nodules is what we aim to explore in this study.
Read the detailed description
Indeterminate lung nodules (6-15 mm) are frequent findings in patients undergoing chest Computed Tomography (CT). In the large randomized controlled Dutch-Belgian lung cancer screening trial NELSON, overall, 9.2% of the screened participants had an initially indeterminate CT scan. To decrease mortality from lung cancer, early identification of malignant lesions among the many lung nodules is crucial. The probability of malignancy depends on size and other factors. It is difficult to determine whether a nodule is malignant on size alone. For further differentiation of a lung nodule, usually, repeated chest CT scanning is performed at 3-6 months up to 2 years to assess nodule growth, and/or 2-deoxy-2-[fluorine-18) fluoro-D-glucose (18F-FDG) Positron Emission Tomography (PET)/CT to evaluate metabolic activity. However, repetitive CT scans are not favoured because of radiation exposure, patiënt anxiety, and potential delay in cancer diagnosis. Furthermore, 18F-FDG PET/CT has thus far insufficiënt sensitivity for detection and characterization of small (in particular < 1 cm) lung nodules, meaning that a negative result does not rule out the presence of cancer, which thus usually requires further follow-up CT scans. Improvement in work-up of indeterminate lung nodules is urgently needed, in particular with the expected introduction of lung cancer screening in the coming years.
In this study, the aim is to derive optimal imaging procedures and to assess the technical performance of the Vision Quadra PET/CT system concerning its feasibility to detect indeterminate lung nodules. Furthermore, this study aims to preliminary explore the sensitivity, specificity, and accuracy of the characterisation of lung nodules using the Vision Quadra PET/CT.
After enrolment, patients will receive a Standard 3 MBq/kg injection of 18F-FDG and undergo whole-body dynamic PET/CT acquisition at 30-60 min post-injection (pi), followed by a 10 min whole-body list-mode PET/CT acquisition. Subsequently, patients will be asked to hold their breath for 15 seconds to assess the added value of a single fast deep-inspiration breath-hold acquisition.
At 120 min pi a second 10 min whole-body list-mode PET/CT will be acquired to potentially further differentiate between inflammation and malignancy.
The list-mode acquisitions can be reprocessed retrospectively with less counts to produce images representing scans collected with lower activity administration or shorter scan times (e.g., a 1 min instead of 10 min PET scan is equivalent to 10% of the injected activity at scan start). Quantitative image analysis results will be correlated with pathology (benign or malignant) of the lung lesion, and results of a previously performed routine-care 18F-FDG PET/CT and CT chest.
- Conditions
- Lung Cancer
- Being tested
- 18F-FDG, PET/CT imaging
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
Patients will receive a single intravenous injection of 3 MBq/kg 18F-FDG
PET/CT imagingRadiation
Patient will undergo 2 CT acquisitions and multiple PET emission scans.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis.
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis.
Measured: up to 2 years
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration) dynamic whole-body acquisition and reconstruction protocol by performing kinetic modelling (Patlak, Ki) analysis.
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration) dynamic whole-body acquisition and reconstruction protocol by performing kinetic modelling (Patlak, Ki) analysis.
Measured: up to 2 years
Description of optimized breath-hold acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis and compare with outcomes 1 and 2.
Description of optimized breath-hold acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis and compare with outcomes 1 and 2.
Measured: up to 2 years
Secondary outcomes (1)
Inventory of early detection and possibly characterization of indeterminate lung nodules
(i.e., to distinguish between benign and malignant tissue) including preliminary exploration of sensitivity, specificity, and accuracy.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start13 Jul 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrienne H Brouwers, MD PhD, Principal investigator, Nuclear Medicine physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463913
- Sponsor's protocol ID
- 202100174
- Status last verified
- Jan 2025
- First submitted
- 22 Mar 2022
- Last updated
- 7 Mar 2025
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-long Field-Of-View Positron Emission Tomography for Characterization of Indeterminate Lung Nodules: a Pilot Study Exploring Opportunities for Clinical Research
- ClinicalTrials.gov ID
- NCT05463913
- Acronym / sponsor ID
- 202100174
- Conditions
- Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 19 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.
Indeterminate lung nodules (6-15mm) are frequent findings in patients undergoing chest CT scanning, but adequate follow-up imaging is currently not in place to facilitate early detection, diagnosis and decision making regarding treatment.
The introduction of long Field-Of-View PET/CT scanners could make a difference in this matter due to the substantial increase in sensitivity allowing optimal image quality. Whether this new technology could provide improved detection and follow-up of indeterminate lung nodules is what we aim to explore in this study.
Detailed description
Indeterminate lung nodules (6-15 mm) are frequent findings in patients undergoing chest Computed Tomography (CT). In the large randomized controlled Dutch-Belgian lung cancer screening trial NELSON, overall, 9.2% of the screened participants had an initially indeterminate CT scan. To decrease mortality from lung cancer, early identification of malignant lesions among the many lung nodules is crucial. The probability of malignancy depends on size and other factors. It is difficult to determine whether a nodule is malignant on size alone. For further differentiation of a lung nodule, usually, repeated chest CT scanning is performed at 3-6 months up to 2 years to assess nodule growth, and/or 2-deoxy-2-[fluorine-18) fluoro-D-glucose (18F-FDG) Positron Emission Tomography (PET)/CT to evaluate metabolic activity. However, repetitive CT scans are not favoured because of radiation exposure, patiënt anxiety, and potential delay in cancer diagnosis. Furthermore, 18F-FDG PET/CT has thus far insufficiënt sensitivity for detection and characterization of small (in particular < 1 cm) lung nodules, meaning that a negative result does not rule out the presence of cancer, which thus usually requires further follow-up CT scans. Improvement in work-up of indeterminate lung nodules is urgently needed, in particular with the expected introduction of lung cancer screening in the coming years.
In this study, the aim is to derive optimal imaging procedures and to assess the technical performance of the Vision Quadra PET/CT system concerning its feasibility to detect indeterminate lung nodules. Furthermore, this study aims to preliminary explore the sensitivity, specificity, and accuracy of the characterisation of lung nodules using the Vision Quadra PET/CT.
After enrolment, patients will receive a Standard 3 MBq/kg injection of 18F-FDG and undergo whole-body dynamic PET/CT acquisition at 30-60 min post-injection (pi), followed by a 10 min whole-body list-mode PET/CT acquisition. Subsequently, patients will be asked to hold their breath for 15 seconds to assess the added value of a single fast deep-inspiration breath-hold acquisition.
At 120 min pi a second 10 min whole-body list-mode PET/CT will be acquired to potentially further differentiate between inflammation and malignancy.
The list-mode acquisitions can be reprocessed retrospectively with less counts to produce images representing scans collected with lower activity administration or shorter scan times (e.g., a 1 min instead of 10 min PET scan is equivalent to 10% of the injected activity at scan start). Quantitative image analysis results will be correlated with pathology (benign or malignant) of the lung lesion, and results of a previously performed routine-care 18F-FDG PET/CT and CT chest.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- able to give informed consent
- signed informed consent
- confirmed indeterminate lung nodule(s) of 6-15 mm in size on CT chest imaging
- routine 18F-FDG PET/CT performed
- scheduled for biopsy or resection of the lung nodules
Key exclusion criteria (6 listed)
- claustrophobia
- pregnant or breastfeeding
- interval of at least 2 weeks between PET scan and last date of systemic anti-cancer therapy to reduce false-negative uptake in lesions
- radiation therapy of the target lung nodule(s)
- uncontrolled diabetes mellitus
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 |
|---|---|---|
| 18F-FDGPatients will receive a single intravenous injection of 3 MBq/kg 18F-FDG | Drug | – |
| PET/CT imagingPatient will undergo 2 CT acquisitions and multiple PET emission scans. | Radiation | – |
Primary outcome
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis.
Time frame: up to 2 years
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis.
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration) dynamic whole-body acquisition and reconstruction protocol by performing kinetic modelling (Patlak, Ki) analysis.
Time frame: up to 2 years
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration) dynamic whole-body acquisition and reconstruction protocol by performing kinetic modelling (Patlak, Ki) analysis.
Description of optimized breath-hold acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis and compare with outcomes 1 and 2.
Time frame: up to 2 years
Description of optimized breath-hold acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis and compare with outcomes 1 and 2.
1 secondary outcome
Inventory of early detection and possibly characterization of indeterminate lung nodules
Time frame: up to 2 years
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 7 Mar 2025.
- 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.
Adrienne H Brouwers, MD PhD principal investigator
Nuclear Medicine physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 18F-FDG and PET/CT imaging in people with Lung Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 inclusion and 6 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 7 Mar 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Adrienne H Brouwers, MD PhD (+31503613093, a.h.brouwers@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of optimized (in terms of e.g. activity dose needed for injection, time of scan duration, post-processing filtering) static whole-body acquisition and reconstruction protocol by performing semi-quantitative (SUV) analysis. (time frame: up to 2 years). 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?
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 7 Mar 2025.