Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT04128332
Eligibility Criteria:
Inclusion Criteria Stage 1:
* Have given written informed consent to participate in stage 1
* Be aged 16 years or over at the time of signing the informed consent form
* Presence of a hypodense pancreatic mass on contrast enhanced CT scan highly suspicious of operable primary pancreatic cancer as assessed by a pancreatic multi-disciplinary team (MDT)
* Have not had pre-operative systemic therapy or radiotherapy
Inclusion Criteria Stage 2:
* Have participated in stage 1 of the study
* Have confirmed histological or cytological diagnosis of primary pancreatic adenocarcinoma OR radiological evidence of pancreatic head mass with supportive cytological or histological findings.
* Be scheduled to undergo pancreatico-duodenectomy (Whipple's) resection.
* Written informed consent to participate in stage 2
* Aged 16 years or over at the time of signing informed consent
* Have not had pre-operative systemic therapy or radiotherapy
* ECOG Performance status 0-1
* Adequate renal function: GFR ≥ 60
Exclusion Criteria:
* Any condition or abnormalities that in the judgement of the investigator/surgeon/clinical oncologist would place the patient at undue risk
* Women who are known to be pregnant
* Previous abdominal radiotherapy
* Women of child-bearing potential who are unwilling to use 2 highly effective forms of contraception during the study treatment period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04128332
Study Brief:
Protocol Section:
NCT04128332