Esophageal CancerNCT05855291
PET/MRI in Predicting the Outcome of Neoadjuvant Chemoradiotherapy With Esophagectomy in Esophageal Cancer Patients
A study testing PET/MRI in people with Esophageal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Integrated PET/MRI has the advantage to assess the metabolism, diffusion, and perfusion parameters of the tumor simultaneously. Recently, PET/MRI has been investigated in several cancers with promising results. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jan 2018to 31 Jul 2021
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy-proven primary esophageal cancer
- Willing to receive therapy
- The ability to provide written informed consent and receive the scheduled scans
Who cannot join
- Woman with pregnancy or during lactation
- A history of other malignancies or concomitant cancers in different anatomical locations
- Not suitable to receive the PET scan such as serum glucose levels of > 200 mg/dL or space phobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Role of Integrated 18FDG-PET/MRI in Predicting the Treatment Outcome of Neoadjuvant Concurrent Chemoradiotherapy Followed by Esophagectomy for Patients With Esophageal Cancer
Integrated PET/MRI has the advantage to assess the metabolism, diffusion, and perfusion parameters of the tumor simultaneously. Recently, PET/MRI has been investigated in several cancers with promising results. In this study, we prospectively investigate the role of multiparametric PET/MRI in evaluating the outcome of patients with esophageal cancer treated by neoadjuvant chemoradiotherapy and surgery.
Read the detailed description
Background:
Esophageal carcinoma is ranked as the 6th leading cancer in Taiwan. In recent years, the survival of patients with esophageal cancer has been improved by the use of neoadjuvant chemoradiotherapy with esophagectomy. But it is reported that only patients who were responsive to neoadjuvant therapy would have prolonged survival. And accurate clinical or imaging modality parameters for prognostic prediction are still lacking.
Traditionally, clinicians rely on endoscopic ultrasound (EUS) and computed tomography (CT) to evaluate the treatment response of esophageal cancer patients. After the neoadjuvant chemotherapy, the accuracy of EUS for assessment of primary tumor or regional nodal sites is reported to be 45-82% or 55-94%, respectively. As for CT, the reported sensitivity is also suboptimal, ranging from 33 to 55%. The specificity is 50-71%. In this regard, 18F-FDG PET/CT has higher sensitivity and specificity of 57-86% and 46-93% than other imaging modalities. But it is still difficult to precisely assess the treatment response depending on these imaging studies.
Functional MRI has been proven to be useful to evaluate treatment responses in various cancers. However, the application of functional MRI in esophageal cancer is limited. One investigator has reported that the apparent diffusion coefficient (ADC) value derived from diffusion MRI (DWI) had the potential to predict the response of esophageal cancer patients. After chemotherapy, the velocity of contrast across the vascular wall was also reported to change substantially in the dynamic contrast MRI (DCE MRI) study.
Integrated PET/MRI has the advantage to perform multiparametric imaging and to assess tumor metabolism (SUV, TLG), ADC, and DCE MRI parameters simultaneously. Recently, PET/MRI has been investigated in several cancers with promising results. In this study, the investigators prospectively explore the role of multiparametric PET/MRI imaging in evaluating the outcome of patients with esophageal cancer.
Material and method:
The study patients receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy. And the functional imaging parameters on PET/MRI are calculated and correlated with the treatment outcome.
Material and method:
The study patients receive 18F-FDG PET/MRI before and during definitive chemoradiotherapy. And the corresponding functional imaging parameters are calculated and correlated with the treatment outcome.
18F-FDG PET/MRI: PET/MRI is performed on a Biograph mMR (Siemens Healthcare, Erlangen, Germany). The PET/MRI system is equipped with 3-T magnetic field strength, total imaging matrix coil technology covering the entire body with multiple integrated radiofrequency surface coils, and a fully functional PET system with avalanche photodiode technology embedded in the magnetic resonance gantry.
Statistical analysis: Overall survival (OS) serves as the main outcome measure. OS is calculated from the date of diagnosis to the date of death or censored at the date of the last follow-up for surviving patients. The cutoff values for the clinical variables and imaging parameters in survival analysis are determined using the log-rank test. Survival curves are plotted using the Kaplan-Meier method. The effect of each individual variable is initially evaluated using univariate analysis. Cox regression models are used to identify the predictors of survival. Two-tailed P values < 0.05 are considered statistically significant.
- Conditions
- Esophageal Cancer
- Being tested
- PET/MRI
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDiagnostic test
The participants receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Integrated PET/MRI | Experimental | The study patients receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy. Receives: Diagnostic Test: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Being calculated from the date of diagnosis to the date of death or censor at the date of the last follow- up for surviving patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start22 Jan 2018
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
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 Chang Gung Memorial HospitalThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yin-Kai Chao, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855291
- Sponsor's protocol ID
- MOST 108-2314-B-182A-021
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chao YK, Chang CB, Chang YC, Chan SC, Chiu CH, Ng SH, Hsieh JC, Wang JH. Baseline and interim [18F]FDG-PET/MRI to assess treatment response and survival in patients with M0 esophageal squamous cell carcinoma treated by curative-intent therapy. Cancer Imaging. 2023 Nov 6;23(1):109. doi: 10.1186/s40644-023-00630-2.
PubMed 37932848
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Integrated 18FDG-PET/MRI in Predicting the Treatment Outcome of Neoadjuvant Concurrent Chemoradiotherapy Followed by Esophagectomy for Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05855291
- Acronym / sponsor ID
- MOST 108-2314-B-182A-021
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 11 May 2023 (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.
Integrated PET/MRI has the advantage to assess the metabolism, diffusion, and perfusion parameters of the tumor simultaneously. Recently, PET/MRI has been investigated in several cancers with promising results. In this study, we prospectively investigate the role of multiparametric PET/MRI in evaluating the outcome of patients with esophageal cancer treated by neoadjuvant chemoradiotherapy and surgery.
Detailed description
Background:
Esophageal carcinoma is ranked as the 6th leading cancer in Taiwan. In recent years, the survival of patients with esophageal cancer has been improved by the use of neoadjuvant chemoradiotherapy with esophagectomy. But it is reported that only patients who were responsive to neoadjuvant therapy would have prolonged survival. And accurate clinical or imaging modality parameters for prognostic prediction are still lacking.
Traditionally, clinicians rely on endoscopic ultrasound (EUS) and computed tomography (CT) to evaluate the treatment response of esophageal cancer patients. After the neoadjuvant chemotherapy, the accuracy of EUS for assessment of primary tumor or regional nodal sites is reported to be 45-82% or 55-94%, respectively. As for CT, the reported sensitivity is also suboptimal, ranging from 33 to 55%. The specificity is 50-71%. In this regard, 18F-FDG PET/CT has higher sensitivity and specificity of 57-86% and 46-93% than other imaging modalities. But it is still difficult to precisely assess the treatment response depending on these imaging studies.
Functional MRI has been proven to be useful to evaluate treatment responses in various cancers. However, the application of functional MRI in esophageal cancer is limited. One investigator has reported that the apparent diffusion coefficient (ADC) value derived from diffusion MRI (DWI) had the potential to predict the response of esophageal cancer patients. After chemotherapy, the velocity of contrast across the vascular wall was also reported to change substantially in the dynamic contrast MRI (DCE MRI) study.
Integrated PET/MRI has the advantage to perform multiparametric imaging and to assess tumor metabolism (SUV, TLG), ADC, and DCE MRI parameters simultaneously. Recently, PET/MRI has been investigated in several cancers with promising results. In this study, the investigators prospectively explore the role of multiparametric PET/MRI imaging in evaluating the outcome of patients with esophageal cancer.
Material and method:
The study patients receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy. And the functional imaging parameters on PET/MRI are calculated and correlated with the treatment outcome.
Material and method:
The study patients receive 18F-FDG PET/MRI before and during definitive chemoradiotherapy. And the corresponding functional imaging parameters are calculated and correlated with the treatment outcome.
18F-FDG PET/MRI: PET/MRI is performed on a Biograph mMR (Siemens Healthcare, Erlangen, Germany). The PET/MRI system is equipped with 3-T magnetic field strength, total imaging matrix coil technology covering the entire body with multiple integrated radiofrequency surface coils, and a fully functional PET system with avalanche photodiode technology embedded in the magnetic resonance gantry.
Statistical analysis: Overall survival (OS) serves as the main outcome measure. OS is calculated from the date of diagnosis to the date of death or censored at the date of the last follow-up for surviving patients. The cutoff values for the clinical variables and imaging parameters in survival analysis are determined using the log-rank test. Survival curves are plotted using the Kaplan-Meier method. The effect of each individual variable is initially evaluated using univariate analysis. Cox regression models are used to identify the predictors of survival. Two-tailed P values < 0.05 are considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated PET/MRI | Experimental | Diagnostic Test: PET/MRIThe study patients receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven primary esophageal cancer
- Willing to receive therapy
- The ability to provide written informed consent and receive the scheduled scans
Key exclusion criteria (3 listed)
- Woman with pregnancy or during lactation
- A history of other malignancies or concomitant cancers in different anatomical locations
- Not suitable to receive the PET scan such as serum glucose levels of > 200 mg/dL or space phobia
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/MRIThe participants receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy. | Diagnostic test | Integrated PET/MRI |
Primary outcome
Overall survival
Time frame: 3 years
Being calculated from the date of diagnosis to the date of death or censor at the date of the last follow- up for surviving patients
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 11 May 2023.
- Derived from this study: PubMed 37932848Chao YK, Chang CB, Chang YC, Chan SC, Chiu CH, Ng SH, Hsieh JC, Wang JH. Baseline and interim [18F]FDG-PET/MRI to assess treatment response and survival in patients with M0 esophageal squamous cell carcinoma treated by curative-intent therapy. Cancer Imaging. 2023 Nov 6;23(1):109. doi: 10.1186/s40644-023-00630-2.
- 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.
Yin-Kai Chao study director
Chang Gung Memorial Hospital
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/MRI in people with Esophageal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 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 11 May 2023. 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 Taiwan. 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?
Overall survival (time frame: 3 years). 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 NCT05855291, 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 11 May 2023.