A new magnetic resonance scanning technology for monitoring therapy effects in patients with Pancreatic cancer.

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10033575Term: Pancreas cancerSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2016-004491-22-DK
• Lead Sponsor: Dept. Clinical Medicine, Aarhus Universit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-03
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Inclusion criteria
•Patients with inoperable (metastatic, locally advanced or localised) histologically or cytologically verified pancreatic adenocarcinoma.
•Scheduled for first-line palliative chemotherapy of any type.
•At least 18 years of age.
•WHO performance status 0-2.
•Measurable or unmeasurable disease.
•Adequate hematologic and organ function, i.e.
ANC at least 1.5
Platlet count >100
Se bilirubin <1.5 UNL
ASAT, ALAT and AP up to 2.5 x UNL, up to 5 x UNL with liver metastases
Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min
INR and aPTT at most 1.5 x UNL, except for patients on AK treatment
•Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test. Safe contraception should be used throughout the study for all other patients.
•Danish speaking
•Able and willing to comply after informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Patients in whom treatment is curatively intended, e.g. patients scheduled for preoperative treatment of marginally resectable disease
•Contraindications to contrast enhanced MRI
•Contraindication to contrast enhanced CT
•Not able or willing to receive chemotherapy
•Patients not willing to participate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Proof of concept study for application of hyperpolarized [1-13C]Pyruvate<br>in magnetic resonance spectroscopy for early in vivo detection of<br>therapeutic effects in treatment of pancreatic cancer;Secondary Objective: Secondary objectives of the trial: To establish whether the sensitivity of<br>MR-hyperpolarized [1-13C]Pyruvate based MR-spectroscopy is high<br>enough for future studies of surgical intervention versus cytotoxic<br>treatment.;Primary end point(s): The scanning program is terminated after 15 complete hyperpolarization scanning procedures in patients with c. pancreatitis - or unacceptable side effects appears;Timepoint(s) of evaluation of this end point: After the first five scanning's to evaluate the applied MR- hyperpolarization scanning sequences

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): After subsequent 10 complete patient scanning's <br>;Timepoint(s) of evaluation of this end point: After completing all 15 hyperpolarization scanning's