Esophageal CancerNCT02424864
4D FDG PET in Esophageal Cancer
A study testing 4d PET-CT in people with Esophageal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- 4d PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to 19 May 2017
- 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 with pathology proven esophageal cancer or tumor highly suspicious for esophageal cancer
- > 18 years
- Written informed consent
Who cannot join
- <18 years
- Possibility of pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
The Netherlands cancer Institute
Amsterdam, North Holland, 1066CX
About this study
Official title: 4D PET-CT Imaging in Esophageal Cancer
FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. The investigators hypothesize that the metabolic signal obtained with motion compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor and lymph nodes.
Read the detailed description
Patients will receive a normal 3D FDG PET-CT scan. By participating in this trial, one extra 4D CT scan will be made. For both the PET and the 4D CT acquisition, the patient gets an abdominal belt around the waist to register breathing motion. No extra FDG PET scan is required for this study. The 4D CT scan is the only intervention which increases the radiation dose exposure compared to the standard PET-CT scan. However, in comparison to the expected radiation dose delivered, if a patient will be treated with curative chemoradiotherapy, this increase in radiation dose is negligible and secondary risks due to this intervention are therefore not increased. For patients who are not eligible for curative treatment the extra dose is also not relevant, given the life expectancy of this group.
- Conditions
- Esophageal Cancer
- Being tested
- 4d PET-CT
- Keywords
- 4D PET-CT
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4d PET-CTOther
Patients will be imaged with 4D-CT images in addition to the normal protocol of FDG-CT image acquisition
| Study group | Role | What they receive |
|---|---|---|
| 4D PET-CT | Other | Other intervention: 4D PET-CT Receives: Other: 4d PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET
Measured: one year
Secondary outcomes (1)
Measurement of SUV max, SUV mean, and SUV peak in 4D versus 3D images of esophageal cancer and lymph nodes and number of suspected involved lymph nodes
measurement of the SUV is a composite measurement in each FDG PET scan
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startAug 2014
- Primary completion19 May 2017
- Study completion19 May 2017
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 Esophageal CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francine Voncken, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424864
- Sponsor's protocol ID
- N14FDG
- Other IDs
- NL45839.031.13
- Status last verified
- Jan 2017
- First submitted
- 30 Mar 2015
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Voncken FEM, Vegt E, van Sandick JW, van Dieren JM, Grootscholten C, Bartels-Rutten A, Takken SL, Sonke JJ, van de Kamer JB, Aleman BMP. Motion-compensated FDG PET/CT for oesophageal cancer. Strahlenther Onkol. 2021 Sep;197(9):791-801. doi: 10.1007/s00066-021-01761-w. Epub 2021 Apr 7.
PubMed 33825916
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D PET-CT Imaging in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02424864
- Acronym / sponsor ID
- N14FDG
- Conditions
- Esophageal Cancer
- Keywords
- 4D PET-CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 23 Apr 2015 (estimated)
- 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.
FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. The investigators hypothesize that the metabolic signal obtained with motion compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor and lymph nodes.
Detailed description
Patients will receive a normal 3D FDG PET-CT scan. By participating in this trial, one extra 4D CT scan will be made. For both the PET and the 4D CT acquisition, the patient gets an abdominal belt around the waist to register breathing motion. No extra FDG PET scan is required for this study. The 4D CT scan is the only intervention which increases the radiation dose exposure compared to the standard PET-CT scan. However, in comparison to the expected radiation dose delivered, if a patient will be treated with curative chemoradiotherapy, this increase in radiation dose is negligible and secondary risks due to this intervention are therefore not increased. For patients who are not eligible for curative treatment the extra dose is also not relevant, given the life expectancy of this group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4D PET-CT | Other | Other: 4d PET-CTOther intervention: 4D PET-CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pathology proven esophageal cancer or tumor highly suspicious for esophageal cancer
- > 18 years
- Written informed consent
Key exclusion criteria (2 listed)
- <18 years
- Possibility of pregnancy
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 |
|---|---|---|
| 4d PET-CTPatients will be imaged with 4D-CT images in addition to the normal protocol of FDG-CT image acquisition | Other | 4D PET-CT |
Primary outcome
The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET
Time frame: one year
1 secondary outcome
Measurement of SUV max, SUV mean, and SUV peak in 4D versus 3D images of esophageal cancer and lymph nodes and number of suspected involved lymph nodes
Time frame: one year
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 28 Sep 2017.
- Derived from this study: PubMed 33825916Voncken FEM, Vegt E, van Sandick JW, van Dieren JM, Grootscholten C, Bartels-Rutten A, Takken SL, Sonke JJ, van de Kamer JB, Aleman BMP. Motion-compensated FDG PET/CT for oesophageal cancer. Strahlenther Onkol. 2021 Sep;197(9):791-801. doi: 10.1007/s00066-021-01761-w. Epub 2021 Apr 7.
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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.
Francine Voncken, MD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4d PET-CT in people with Esophageal Cancer, run by The Netherlands Cancer Institute 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 3 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: finished, as of the sponsor's last update on 28 Sep 2017. 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?
The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET (time frame: one year). 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 NCT02424864, 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 28 Sep 2017.