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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
NCT02433301 |
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Date of registration:
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29/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PET/MR-imaging to Differentiate Between Responders and Non-responders Receiving Preoperative Chemotherapy
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Scientific title:
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PET/MR-imaging and Circulating Tumour Cells to Evaluate the Response of Chemotherapy in Patients With Gastroesophageal Junction Cancer |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02433301 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with histologically verified adenocarcinoma of the Gastroesophageal junction
and assessed as operable.
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastroesophageal Junction Cancer
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Primary Outcome(s)
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To Study wether molecular PET/MR-imaging can measure a significant difference between responders and non-responders receiving perioperative chemotherapy
[Time Frame: 8 Months]
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Secondary Outcome(s)
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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]
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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]
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Secondary ID(s)
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H-1-2014-076
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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