Esophageal TumorPET/MRI-ECNCT02839109
PET-CT vs DWI-MRI in Response Evaluation in Esophageal Cancer
An observational study of Esophageal Tumor, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
In patients with esophageal cancer (EC) neo-adjuvant chemoradiation (nCRT) followed by surgery with curative intent leads to objective responses in 45 to 60%, whereas 20-35% of the patients had no residual tumor (ypT0N0) at pathologic examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Tumor
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to Aug 2017
- Phase
- Observational
- 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
Study population: The study group consists of patients with potentially curative (R0) resectable EC (T2-T4aN0M0/T1-T4aN1-3M0). These patients should be eligible for neo-adjuvant chemo-radiotherapy (CRT) including; performance/WHO ≤ 2; age > 18 yrs; hematology, electrolytes, liver and renal tests within normal range; no prior radio- or chemotherapy that would influence treatment for EC; no other malignancies (except basal cell carcinoma of the skin and carcinoma in situ), no active infect at the time of imaging, written informed consent.
Who may be able to join
- Histologically proven esophageal cancer (SCC and AC).
- Age of 18 years or older.
- Able to give written informed consent before registration.
- T2-T4aN0M0 or T1-T4aN1-3M0 esophageal cancer.
- Potentially curatively (R0) resectable tumor.
- Tumor have sufficient FDG-baseline uptake.
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- Able to tolerate PET-CT and DWI-MRI as required by protocol.
- Eligible for neo-adjuvant chemoradiotherapy (nCRT), including KPScore ≥ 70% / WHO>2; adequate renal, hepatic, hematological function.
- No prior chemotherapy or mediastinal radiotherapy allowed.
Who cannot join
- Non-resectable tumors: clinical or pathologic (T4b/R1-2 resections).
- Proven distant metastases.
- Prior malignancy except in-situ cervical lesions or non-melanoma skin cancer in the past 5 years.
- Poorly controlled diabetes
- Medical comorbidity preventing from surgery/preop CRT
- General contraindications to MRI:
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- implanted pacemaker/serious claustrophobia
- aneurysmal clips/metal implants in field of view
- 6. Major obesity (BMI > 40). 7. Active esophagitis. 8. Breast feeding/Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET-CT and DWI-MRI in Evaluating and Predicting Response to Neo-adjuvant Chemoradiotherapy in Esophageal Cancer Patients
In patients with esophageal cancer (EC) neo-adjuvant chemoradiation (nCRT) followed by surgery with curative intent leads to objective responses in 45 to 60%, whereas 20-35% of the patients had no residual tumor (ypT0N0) at pathologic examination. The absolute survival benefit of response to nCRT is 15%, but still 14% of the patients develop locoregional failure in the CROSS trial. 18F-fluorodeoxyglucose positron emission tomography with computed tomography ((FDG-PET-CT) is able to distinct responders from non-responders, but still misses significant clinical evidence. Whole-body diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) has shown potential benefits, which might be enhanced by combining both methods. PET/CT and DWI-MRI more precisely correlate anatomic and metabolic FDG-avid lesions and seem to assess post-treatment changes, especially regarding nodal staging. Both techniques claim an important role in selection of patients with clinical complete response (cCR) and indirectly with pathologic complete response (pCR) after nCRT. However, the exact role and complementary effects of both techniques is still unknown.
For appropriate judgment of response, secure standard endoscopic ultrasonography (EUS) with fine needle aspiration (FNA) / biopsy of potential suspected lesions, both nodal or residual tumor, seen on PET/CT or DWI/MRI or during EUS will be performed <2 weeks before surgery, approximately 6-10 weeks after nCRT and compared with the situation at primary staging. Patients with clinical complete response (cCR) resembling pathologic response (pCR= ypT0N0) after nCRT may refrain from surgical resection and related morbidity and mortality. However, patients without early (2wk after commencement) response during nCRT course may not benefit from nCRT.
DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Apparent diffusion coefficient (ADC), which indirectly measures tissue density, can be used to determine the likelihood of tumor response to treatment. High ADC before treatment has shown to predict an unfavorable response. Tumors with low ADC values on presentation generally respond better to treatment. An increased ADC in patients during and after nCRT could be used to predict early pathologic response i.e. discrimination of "responders and non-responders" to nCRT.
Read the detailed description
DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Tumor hypoxia mediates chemoradiation resistance, leading to selection of aggressive tumor cell clones with the capacity to evade tumor microenvironment by increased anaerobic glycolysis and angiogenesis. Apparent diffusion coefficient (ADC), which indirectly measures tissue density, can be used to determine the likelihood of tumor response to treatment. High ADC before treatment has shown to predict an unfavorable response. Tumors with low ADC values on presentation generally respond better to treatment. An increased ADC in patients during and after nCRT could be used to predict early pathologic response i.e. discrimination of "responders and non-responders" to nCRT.
- Conditions
- Esophageal Tumor
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Within 2 weeks (early response) and at 6-10 weeks (late response)
Measured: Assessing clinical and pathologic response
Secondary outcomes (1)
Disease free survival (DFS)
Measured: at 6 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startFeb 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal TumorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Plukker, MD, PhD, Principal investigator, Department of Surgical Oncology, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839109
- Sponsor's protocol ID
- NL49621.042.14
- Acronym
- PET/MRI-EC
- Status last verified
- Feb 2024
- First submitted
- 2 May 2016
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The results based on data of this study will be published in medical scientific papers. Moreover the data may be used for meta-analyses or conjoined research.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-CT and DWI-MRI in Evaluating and Predicting Response to Neo-adjuvant Chemoradiotherapy in Esophageal Cancer Patients
- ClinicalTrials.gov ID
- NCT02839109
- Acronym / sponsor ID
- PET/MRI-EC / NL49621.042.14
- Conditions
- Esophageal Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Jul 2016 (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.
In patients with esophageal cancer (EC) neo-adjuvant chemoradiation (nCRT) followed by surgery with curative intent leads to objective responses in 45 to 60%, whereas 20-35% of the patients had no residual tumor (ypT0N0) at pathologic examination. The absolute survival benefit of response to nCRT is 15%, but still 14% of the patients develop locoregional failure in the CROSS trial. 18F-fluorodeoxyglucose positron emission tomography with computed tomography ((FDG-PET-CT) is able to distinct responders from non-responders, but still misses significant clinical evidence. Whole-body diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) has shown potential benefits, which might be enhanced by combining both methods. PET/CT and DWI-MRI more precisely correlate anatomic and metabolic FDG-avid lesions and seem to assess post-treatment changes, especially regarding nodal staging. Both techniques claim an important role in selection of patients with clinical complete response (cCR) and indirectly with pathologic complete response (pCR) after nCRT. However, the exact role and complementary effects of both techniques is still unknown.
For appropriate judgment of response, secure standard endoscopic ultrasonography (EUS) with fine needle aspiration (FNA) / biopsy of potential suspected lesions, both nodal or residual tumor, seen on PET/CT or DWI/MRI or during EUS will be performed <2 weeks before surgery, approximately 6-10 weeks after nCRT and compared with the situation at primary staging. Patients with clinical complete response (cCR) resembling pathologic response (pCR= ypT0N0) after nCRT may refrain from surgical resection and related morbidity and mortality. However, patients without early (2wk after commencement) response during nCRT course may not benefit from nCRT.
DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Apparent diffusion coefficient (ADC), which indirectly measures tissue density, can be used to determine the likelihood of tumor response to treatment. High ADC before treatment has shown to predict an unfavorable response. Tumors with low ADC values on presentation generally respond better to treatment. An increased ADC in patients during and after nCRT could be used to predict early pathologic response i.e. discrimination of "responders and non-responders" to nCRT.
Detailed description
DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Tumor hypoxia mediates chemoradiation resistance, leading to selection of aggressive tumor cell clones with the capacity to evade tumor microenvironment by increased anaerobic glycolysis and angiogenesis. Apparent diffusion coefficient (ADC), which indirectly measures tissue density, can be used to determine the likelihood of tumor response to treatment. High ADC before treatment has shown to predict an unfavorable response. Tumors with low ADC values on presentation generally respond better to treatment. An increased ADC in patients during and after nCRT could be used to predict early pathologic response i.e. discrimination of "responders and non-responders" to nCRT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group consists of patients with potentially curative (R0) resectable EC (T2-T4aN0M0/T1-T4aN1-3M0). These patients should be eligible for neo-adjuvant chemo-radiotherapy (CRT) including; performance/WHO ≤ 2; age > 18 yrs; hematology, electrolytes, liver and renal tests within normal range; no prior radio- or chemotherapy that would influence treatment for EC; no other malignancies (except basal cell carcinoma of the skin and carcinoma in situ), no active infect at the time of imaging, written informed consent.
Key inclusion criteria (9 listed)
- Histologically proven esophageal cancer (SCC and AC).
- Age of 18 years or older.
- Able to give written informed consent before registration.
- T2-T4aN0M0 or T1-T4aN1-3M0 esophageal cancer.
- Potentially curatively (R0) resectable tumor.
Key exclusion criteria (9 listed)
- Non-resectable tumors: clinical or pathologic (T4b/R1-2 resections).
- Proven distant metastases.
- Prior malignancy except in-situ cervical lesions or non-melanoma skin cancer in the past 5 years.
- Poorly controlled diabetes
- Medical comorbidity preventing from surgery/preop CRT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor response
Time frame: Assessing clinical and pathologic response
Within 2 weeks (early response) and at 6-10 weeks (late response)
1 secondary outcome
Disease free survival (DFS)
Time frame: at 6 months, 1 year and 2 years
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 Feb 2024.
- Individual participant dataSharing planned: Yes. The results based on data of this study will be published in medical scientific papers. Moreover the data may be used for meta-analyses or conjoined research.
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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.
John Plukker, MD, PhD principal investigator
Department of Surgical Oncology, University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Tumor, 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 9 inclusion and 9 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 Feb 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 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?
Tumor response (time frame: Assessing clinical and pathologic response). 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 28 Feb 2024.