Gastroesophageal Junction CancerNCT02433301
PET/MR-imaging to Differentiate Between Responders and Non-responders Receiving Preoperative Chemotherapy
An observational study of Gastroesophageal Junction Cancer, run by Rikshospitalet University Hospital at 1 site in Denmark.
Trial summary
The incidence of malignity in the gastroesophageal junction (GEJ) is rising in Denmark, 400 new cases annually 1. 60% of the patients with GEJ cancer have disseminated disease (M1-stage) at time of diagnosis and are consequently unable to undergo curative intended surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Junction Cancer
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Jun 2016
- 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: All patients referred to the Department of Surgical Gastroenterology, Rigshospitalet, with histologically verified adenocarcinoma of the Gastroesophageal junction and assessed as operable. Informed consent is required from each patient
Who may be able to join
- Patients with histologically verified adenocarcinoma of the Gastroesophageal junction and assessed as operable.
Who cannot join
- Under 18 of age
- Not given informed consent
- Other histological cancers besides adenocarcinoma
- Metal in the body that would contraindicate MR-imaging
- Allergies for contrast
- Claustrophobia
- Not a candidate for perioperative chemotherapy and surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET/MR-imaging and Circulating Tumour Cells to Evaluate the Response of Chemotherapy in Patients With Gastroesophageal Junction Cancer
The incidence of malignity in the gastroesophageal junction (GEJ) is rising in Denmark, 400 new cases annually 1. 60% of the patients with GEJ cancer have disseminated disease (M1-stage) at time of diagnosis and are consequently unable to undergo curative intended surgery. The prognosis is poor, with 5-year survival rates of approximately 2 % for these 60% and the treatment only consists of palliative therapy 1. For the remaining approximately 40 % who are assessed as candidates for curative intended surgery, the 5-year survival rate is 33 % 1. This emphasizes the need for further research and knowledge concerning tumour biology and spontaneous course of the disease.
In Denmark, all cancer patients are enrolled in a specific cancer program. The primary diagnostic work-up for GEJ cancers includes gastroscopy with biopsy, blood samples, ultrasonography scan, Positronemissionstomography (PET) and Computed tomography (CT) alone or PET/CT in combination 2. From these parameters physicians determine resectability and TNM-stage (tumour staging), which is substantial for the prognosis and future treatment. The primary goal is to achieve a macroscopically resection of tumour and lymphnodes in relation to the stomach and oesophagus (Esophagectomi a.m. Ivor Lewis and D1+ lymphadenectomy in the abdomen and thorax). In addition to surgery, patients receive perioperative chemotherapy, which consist of three series of chemotherapy preoperative and three series postoperative approximately 21-28 days after surgery.
Read more
Approximately 12.6 % of patients receiving perioperative chemotherapy prior to surgery will have disease progression due to chemotherapy resistance during the therapy 3. This unintentionally leads to shifting these patients from the resectable group to non-resectable group (palliative treatment). Thus, the possibility for detecting response to perioperative chemotherapy is of great interest. A paradigm shift towards an individualised tailored therapy form has emerged in recent years, which potentially require a higher need for diagnosis on molecular level. Today most molecular biological methods apply tissue samples for in-vitro analyses, but new radiological tools provide opportunity for non-invasive examinations; for example PET can with a radioactive sugar compound: Flour-18 deoxyglucose (18F-FDG). This compound is injected through a catheter in a larger vein (media cubiti vein) and absorbed in cells with increased metabolism - especially cancer cells. A PET scanner registers the absorption; this radiology modality can provide valid information, which is essential for non-invasive tumour staging and monitoring response under a specific therapy.
A new diagnostic modality is PET scan combinated with magnetic resonance (PET/MR) simultaneously. So far, no studies have conducted an evaluation of simultaneous PET/MR scan to assess the perioperative chemotherapy response in patients with GEJ cancer. However, some studies suggest that commercially available PET/MR scanner might contribute in a diagnostic elucidation 6. Simultaneous PET/MR scan might in theory minimize the misinterpretations of potential response changes after chemotherapy, which can appear in the interval between separate PET, CT and MR scans 4,5,7. Studies have found PET scan of GEJ cancer could be helpful as a prognostic tool to differentiate between responders and non-responders during chemotherapy 9. Standardized uptake value (SUV) is a unit that display the absorption of 18F-FDG and is used routinely to quantify tumour glucose metabolism in PET scan 8. A change of more than 35 % in SUV measurements before and after the induction of chemotherapy is considered as the definition of responders and non-responders in earlier studies 9.
The MR technique is based on magnetic fields and radio waves. Diffusion Weighted Imaging (DWI) is a non-invasive MR-modality, which measures the changes in water diffusion (Brownian movements) throughout tissue. These changes are measured in Apparent Diffusion Coefficient (ADC), a parameter derived from DWI and reflects the change in diffusion 7. ADC and DWI can be used to differentiate between benign and malignant tumours, due to a larger cell density in malignant tumours. Consequently, malignant tissue has a decreased diffusion relative to normal tissue. ADC has been used as a factor in some studies to predict the response to chemotherapy 10. A single study has shown a rise in ADC-value two weeks after initiation of chemotherapy in patients with GEJ cancer, and demonstrated that the percentage change in ADC-value between the groups (responders and non-responders) is significantly different 11. Simultaneous PET- and MR scan might be very useful to evaluate the response to chemotherapy in patients with GEJ cancer compared with these parameters alone. The opportunity for a more individualised tailored treatment in future might be possible with PET/MR.
- Conditions
- Gastroesophageal Junction Cancer
- Keywords
- chemotherapy, GEJ cancer, PET/MR-imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
To Study wether molecular PET/MR-imaging can measure a significant difference between responders and non-responders receiving perioperative chemotherapy
Measured: 8 Months
Secondary outcomes (2)
To examine if DWI and ADC can identify lymph nodes suspected for malignancy and correlate these with findings from the resected tumour preparation
Measured: 8 Months
To correlate a possible difference in responders and non-responders to survival, disease progression prior to surgery, inoperability, surgical complications and tolerance of both preoperative- and postoperative chemotherapy
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Junction 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rikshospitalet University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Belmouhand, Rikshospitalet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433301
- Sponsor's protocol ID
- H-1-2014-076
- Status last verified
- Oct 2016
- First submitted
- 29 Apr 2015
- Last updated
- 5 Oct 2016
- Results posted
- No
Publications
Larsen AC, Hollander C, Duval L, Schonnemann K, Achiam M, Pfeiffer P, Yilmaz MK, Thorlacius-Ussing O, Baeksgaard L, Ladekarl M. A nationwide retrospective study of perioperative chemotherapy for gastroesophageal adenocarcinoma: tolerability, outcome, and prognostic factors. Ann Surg Oncol. 2015 May;22(5):1540-7. doi: 10.1245/s10434-014-4127-2. Epub 2014 Oct 28.
PubMed 25348777Gambhir SS. Molecular imaging of cancer with positron emission tomography. Nat Rev Cancer. 2002 Sep;2(9):683-93. doi: 10.1038/nrc882.
PubMed 12209157Basu S, Alavi A. Unparalleled contribution of 18F-FDG PET to medicine over 3 decades. J Nucl Med. 2008 Oct;49(10):17N-21N, 37N. No abstract available.
PubMed 18832112Thoeny HC, Ross BD. Predicting and monitoring cancer treatment response with diffusion-weighted MRI. J Magn Reson Imaging. 2010 Jul;32(1):2-16. doi: 10.1002/jmri.22167.
PubMed 20575076Jadvar H, Colletti PM. Competitive advantage of PET/MRI. Eur J Radiol. 2014 Jan;83(1):84-94. doi: 10.1016/j.ejrad.2013.05.028. Epub 2013 Jun 18.
PubMed 23791129Rakheja R, Chandarana H, DeMello L, Jackson K, Geppert C, Faul D, Glielmi C, Friedman KP. Correlation between standardized uptake value and apparent diffusion coefficient of neoplastic lesions evaluated with whole-body simultaneous hybrid PET/MRI. AJR Am J Roentgenol. 2013 Nov;201(5):1115-9. doi: 10.2214/AJR.13.11304.
PubMed 24147485Zhu W, Xing L, Yue J, Sun X, Sun X, Zhao H, Yu J. Prognostic significance of SUV on PET/CT in patients with localised oesophagogastric junction cancer receiving neoadjuvant chemotherapy/chemoradiation:a systematic review and meta-analysis. Br J Radiol. 2012 Sep;85(1017):e694-701. doi: 10.1259/bjr/29946900. Epub 2012 Feb 14.
PubMed 22337686Padhani AR, Liu G, Koh DM, Chenevert TL, Thoeny HC, Takahara T, Dzik-Jurasz A, Ross BD, Van Cauteren M, Collins D, Hammoud DA, Rustin GJ, Taouli B, Choyke PL. Diffusion-weighted magnetic resonance imaging as a cancer biomarker: consensus and recommendations. Neoplasia. 2009 Feb;11(2):102-25. doi: 10.1593/neo.81328.
PubMed 19186405Weber MA, Bender K, von Gall CC, Stange A, Grunberg K, Ott K, Haberkorn U, Kauczor HU, Zechmann C. Assessment of diffusion-weighted MRI and 18F-fluoro-deoxyglucose PET/CT in monitoring early response to neoadjuvant chemotherapy in adenocarcinoma of the esophagogastric junction. J Gastrointestin Liver Dis. 2013 Mar;22(1):45-52.
PubMed 23539390
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MR-imaging and Circulating Tumour Cells to Evaluate the Response of Chemotherapy in Patients With Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT02433301
- Acronym / sponsor ID
- H-1-2014-076
- Conditions
- Gastroesophageal Junction Cancer
- Keywords
- chemotherapy, GEJ cancer, PET/MR-imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rikshospitalet University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 May 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.
The incidence of malignity in the gastroesophageal junction (GEJ) is rising in Denmark, 400 new cases annually 1. 60% of the patients with GEJ cancer have disseminated disease (M1-stage) at time of diagnosis and are consequently unable to undergo curative intended surgery. The prognosis is poor, with 5-year survival rates of approximately 2 % for these 60% and the treatment only consists of palliative therapy 1. For the remaining approximately 40 % who are assessed as candidates for curative intended surgery, the 5-year survival rate is 33 % 1. This emphasizes the need for further research and knowledge concerning tumour biology and spontaneous course of the disease.
In Denmark, all cancer patients are enrolled in a specific cancer program. The primary diagnostic work-up for GEJ cancers includes gastroscopy with biopsy, blood samples, ultrasonography scan, Positronemissionstomography (PET) and Computed tomography (CT) alone or PET/CT in combination 2. From these parameters physicians determine resectability and TNM-stage (tumour staging), which is substantial for the prognosis and future treatment. The primary goal is to achieve a macroscopically resection of tumour and lymphnodes in relation to the stomach and oesophagus (Esophagectomi a.m. Ivor Lewis and D1+ lymphadenectomy in the abdomen and thorax). In addition to surgery, patients receive perioperative chemotherapy, which consist of three series of chemotherapy preoperative and three series postoperative approximately 21-28 days after surgery.
Approximately 12.6 % of patients receiving perioperative chemotherapy prior to surgery will have disease progression due to chemotherapy resistance during the therapy 3. This unintentionally leads to shifting these patients from the resectable group to non-resectable group (palliative treatment). Thus, the possibility for detecting response to perioperative chemotherapy is of great interest. A paradigm shift towards an individualised tailored therapy form has emerged in recent years, which potentially require a higher need for diagnosis on molecular level. Today most molecular biological methods apply tissue samples for in-vitro analyses, but new radiological tools provide opportunity for non-invasive examinations; for example PET can with a radioactive sugar compound: Flour-18 deoxyglucose (18F-FDG). This compound is injected through a catheter in a larger vein (media cubiti vein) and absorbed in cells with increased metabolism - especially cancer cells. A PET scanner registers the absorption; this radiology modality can provide valid information, which is essential for non-invasive tumour staging and monitoring response under a specific therapy.
A new diagnostic modality is PET scan combinated with magnetic resonance (PET/MR) simultaneously. So far, no studies have conducted an evaluation of simultaneous PET/MR scan to assess the perioperative chemotherapy response in patients with GEJ cancer. However, some studies suggest that commercially available PET/MR scanner might contribute in a diagnostic elucidation 6. Simultaneous PET/MR scan might in theory minimize the misinterpretations of potential response changes after chemotherapy, which can appear in the interval between separate PET, CT and MR scans 4,5,7. Studies have found PET scan of GEJ cancer could be helpful as a prognostic tool to differentiate between responders and non-responders during chemotherapy 9. Standardized uptake value (SUV) is a unit that display the absorption of 18F-FDG and is used routinely to quantify tumour glucose metabolism in PET scan 8. A change of more than 35 % in SUV measurements before and after the induction of chemotherapy is considered as the definition of responders and non-responders in earlier studies 9.
The MR technique is based on magnetic fields and radio waves. Diffusion Weighted Imaging (DWI) is a non-invasive MR-modality, which measures the changes in water diffusion (Brownian movements) throughout tissue. These changes are measured in Apparent Diffusion Coefficient (ADC), a parameter derived from DWI and reflects the change in diffusion 7. ADC and DWI can be used to differentiate between benign and malignant tumours, due to a larger cell density in malignant tumours. Consequently, malignant tissue has a decreased diffusion relative to normal tissue. ADC has been used as a factor in some studies to predict the response to chemotherapy 10. A single study has shown a rise in ADC-value two weeks after initiation of chemotherapy in patients with GEJ cancer, and demonstrated that the percentage change in ADC-value between the groups (responders and non-responders) is significantly different 11. Simultaneous PET- and MR scan might be very useful to evaluate the response to chemotherapy in patients with GEJ cancer compared with these parameters alone. The opportunity for a more individualised tailored treatment in future might be possible with PET/MR.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the Department of Surgical Gastroenterology, Rigshospitalet, with histologically verified adenocarcinoma of the Gastroesophageal junction and assessed as operable. Informed consent is required from each patient
Key inclusion criteria (1 listed)
- Patients with histologically verified adenocarcinoma of the Gastroesophageal junction and assessed as operable.
Key exclusion criteria (7 listed)
- Under 18 of age
- Not given informed consent
- Other histological cancers besides adenocarcinoma
- Metal in the body that would contraindicate MR-imaging
- Allergies for contrast
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
To Study wether molecular PET/MR-imaging can measure a significant difference between responders and non-responders receiving perioperative chemotherapy
Time frame: 8 Months
2 secondary outcomes
To examine if DWI and ADC can identify lymph nodes suspected for malignancy and correlate these with findings from the resected tumour preparation
Time frame: 8 Months
To correlate a possible difference in responders and non-responders to survival, disease progression prior to surgery, inoperability, surgical complications and tolerance of both preoperative- and postoperative chemotherapy
Time frame: 8 Months
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 5 Oct 2016.
- Background: PubMed 25348777Larsen AC, Hollander C, Duval L, Schonnemann K, Achiam M, Pfeiffer P, Yilmaz MK, Thorlacius-Ussing O, Baeksgaard L, Ladekarl M. A nationwide retrospective study of perioperative chemotherapy for gastroesophageal adenocarcinoma: tolerability, outcome, and prognostic factors. Ann Surg Oncol. 2015 May;22(5):1540-7. doi: 10.1245/s10434-014-4127-2. Epub 2014 Oct 28.
- Background: PubMed 12209157Gambhir SS. Molecular imaging of cancer with positron emission tomography. Nat Rev Cancer. 2002 Sep;2(9):683-93. doi: 10.1038/nrc882.
- Background: PubMed 18832112Basu S, Alavi A. Unparalleled contribution of 18F-FDG PET to medicine over 3 decades. J Nucl Med. 2008 Oct;49(10):17N-21N, 37N. No abstract available.
- Background: PubMed 20575076Thoeny HC, Ross BD. Predicting and monitoring cancer treatment response with diffusion-weighted MRI. J Magn Reson Imaging. 2010 Jul;32(1):2-16. doi: 10.1002/jmri.22167.
- Background: PubMed 23791129Jadvar H, Colletti PM. Competitive advantage of PET/MRI. Eur J Radiol. 2014 Jan;83(1):84-94. doi: 10.1016/j.ejrad.2013.05.028. Epub 2013 Jun 18.
- Background: PubMed 24147485Rakheja R, Chandarana H, DeMello L, Jackson K, Geppert C, Faul D, Glielmi C, Friedman KP. Correlation between standardized uptake value and apparent diffusion coefficient of neoplastic lesions evaluated with whole-body simultaneous hybrid PET/MRI. AJR Am J Roentgenol. 2013 Nov;201(5):1115-9. doi: 10.2214/AJR.13.11304.
- Background: PubMed 22337686Zhu W, Xing L, Yue J, Sun X, Sun X, Zhao H, Yu J. Prognostic significance of SUV on PET/CT in patients with localised oesophagogastric junction cancer receiving neoadjuvant chemotherapy/chemoradiation:a systematic review and meta-analysis. Br J Radiol. 2012 Sep;85(1017):e694-701. doi: 10.1259/bjr/29946900. Epub 2012 Feb 14.
- Background: PubMed 19186405Padhani AR, Liu G, Koh DM, Chenevert TL, Thoeny HC, Takahara T, Dzik-Jurasz A, Ross BD, Van Cauteren M, Collins D, Hammoud DA, Rustin GJ, Taouli B, Choyke PL. Diffusion-weighted magnetic resonance imaging as a cancer biomarker: consensus and recommendations. Neoplasia. 2009 Feb;11(2):102-25. doi: 10.1593/neo.81328.
- Background: PubMed 23539390Weber MA, Bender K, von Gall CC, Stange A, Grunberg K, Ott K, Haberkorn U, Kauczor HU, Zechmann C. Assessment of diffusion-weighted MRI and 18F-fluoro-deoxyglucose PET/CT in monitoring early response to neoadjuvant chemotherapy in adenocarcinoma of the esophagogastric junction. J Gastrointestin Liver Dis. 2013 Mar;22(1):45-52.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastroesophageal Junction Cancer, run by Rikshospitalet University Hospital at 1 site in Denmark.
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 1 inclusion and 7 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 5 Oct 2016. 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 Denmark. 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?
To Study wether molecular PET/MR-imaging can measure a significant difference between responders and non-responders receiving perioperative chemotherapy (time frame: 8 Months). 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 NCT02433301, which also lists 9 linked publications.
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 5 Oct 2016.