Breast CancerNCT03457506
Intra-individual Comparison of Conventional and Digital PET/CT Scanners
A study testing Digital PET/CT scan in people with Breast Cancer and Lung Cancer, run by Isala at 1 site in Netherlands.
Trial summary
In this study, the investigators will analyze the impact of digital PET/CT on the final diagnostic conclusion of the scan in patients with lung cancer, breast cancer, esophageal cancer and a group of mescellaneous cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Esophageal Cancer
- What is being tested?
- Digital PET/CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Jan 2018to 13 Sep 2019
- 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
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- referred to Isala for a clinically indicated FDG-PET/CT scan
- suspected or proven lung cancer, esophageal cancer, breast cancer or miscellaneous cancer, either as a primary diagnosis or follow-up study
- signed informed consent
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- age < 18 years
- incapacitated adults
- prisoners
- pregnant patients
- unable to undergo two consecutive PET/CT scans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-individual Patient-based Comparison of Conventional and Digital PET/CT Scanners
In this study, the investigators will analyze the impact of digital PET/CT on the final diagnostic conclusion of the scan in patients with lung cancer, breast cancer, esophageal cancer and a group of mescellaneous cancers.
Read the detailed description
There will be a single injection of the PET radiopharmaceutical FDG, followed by a conventional PET/CT scan and a digital PET scan, in this order or vice versa.
- Conditions
- Breast Cancer, Lung Cancer, Esophageal Cancer, Miscellaneous Neoplasm
- Being tested
- Digital PET/CT scan
- Keywords
- Cancer, Digital pet, Conventional pet
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital PET/CT scanDiagnostic test
The digital PET/CT scan will be acquired before or after the conventional PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergo a digital PET/CT | Other | Single arm prospective study of paired PET scans. Patients who are referred to the nuclear medicine department to undergo a PET scan, will undergo a PET/CT scan on the conventional scanner as well as the digital PET/CT scanner. Receives: Diagnostic Test: Digital PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic outcome of the PET/CT study
Measured: approximately 2 hours
Secondary outcomes (1)
PET image quality
Measured: approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start8 Jan 2018
- Primary completion13 Sep 2019
- Study completion13 Sep 2019
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 Breast 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
- All included patients will have two PET scans, one on the conventional PET (Ingenuity TF, Philips Healthcare) and one on the digital PET (Vereos, Philips Healthcare). The order of the two PET scans will differ per patient.
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Piet Jager, Isala
- Investigators
- Pieter L Jager, MD PhD, Principal investigator, p.l.jager@isala.nl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457506
- Sponsor's protocol ID
- NL52329.075.15
- Status last verified
- Sep 2019
- First submitted
- 5 Dec 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koopman D, Jager PL, Slump CH, Knollema S, van Dalen JA. SUV variability in EARL-accredited conventional and digital PET. EJNMMI Res. 2019 Dec 10;9(1):106. doi: 10.1186/s13550-019-0569-7.
PubMed 31823097
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Patient-based Comparison of Conventional and Digital PET/CT Scanners
- ClinicalTrials.gov ID
- NCT03457506
- Acronym / sponsor ID
- NL52329.075.15
- Conditions
- Breast Cancer, Lung Cancer, Esophageal Cancer, Miscellaneous Neoplasm
- Keywords
- Cancer, Digital pet, Conventional pet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 7 Mar 2018 (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.
In this study, the investigators will analyze the impact of digital PET/CT on the final diagnostic conclusion of the scan in patients with lung cancer, breast cancer, esophageal cancer and a group of mescellaneous cancers.
Detailed description
There will be a single injection of the PET radiopharmaceutical FDG, followed by a conventional PET/CT scan and a digital PET scan, in this order or vice versa.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All included patients will have two PET scans, one on the conventional PET (Ingenuity TF, Philips Healthcare) and one on the digital PET (Vereos, Philips Healthcare). The order of the two PET scans will differ per patient.
| Arm | Type | Receives |
|---|---|---|
| Patients undergo a digital PET/CT | Other | Diagnostic Test: Digital PET/CT scanSingle arm prospective study of paired PET scans. Patients who are referred to the nuclear medicine department to undergo a PET scan, will undergo a PET/CT scan on the conventional scanner as well as the digital PET/CT scanner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- referred to Isala for a clinically indicated FDG-PET/CT scan
- suspected or proven lung cancer, esophageal cancer, breast cancer or miscellaneous cancer, either as a primary diagnosis or follow-up study
- signed informed consent
Key exclusion criteria (6 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- age < 18 years
- incapacitated adults
- prisoners
- pregnant patients
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 |
|---|---|---|
| Digital PET/CT scanThe digital PET/CT scan will be acquired before or after the conventional PET/CT scan. | Diagnostic test | Patients undergo a digital PET/CT |
Primary outcome
Diagnostic outcome of the PET/CT study
Time frame: approximately 2 hours
1 secondary outcome
PET image quality
Time frame: approximately 2 hours
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 19 Sep 2019.
- Derived from this study: PubMed 31823097Koopman D, Jager PL, Slump CH, Knollema S, van Dalen JA. SUV variability in EARL-accredited conventional and digital PET. EJNMMI Res. 2019 Dec 10;9(1):106. doi: 10.1186/s13550-019-0569-7.
- 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.
Pieter L Jager, MD PhD principal investigator
p.l.jager@isala.nl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital PET/CT scan in people with Breast Cancer and Lung Cancer, run by Isala 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 4 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: finished, as of the sponsor's last update on 19 Sep 2019. 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.
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?
Diagnostic outcome of the PET/CT study (time frame: approximately 2 hours). 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 NCT03457506, 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 19 Sep 2019.