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

Early detection of effects of chemotherapy in pancreatic cancer patients – a study using MR-hyperpolarization scanning based on hyperpolarized Pyruvate (13C) injection

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004491-22-DK

Enrollment

Registered

2017-01-03

Start date

2017-09-01

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 20.0 Level: LLT Classification code 10033575 Term: Pancreas cancer System Organ Class: 100000004864

Interventions

Product Name: [1-13C]Pyruvate Product Code: [1-13C]Pyruvate Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: SODIUM PYRUVATE Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 ;Main Objective: Proof of concept study for application of hyperpolarized [1-13C]Pyruvate in magnetic resonance spectroscopy for early in vivo detection of therapeutic effects in treatment of pancreatic cancer;Secondary Objective: Secondary objectives of the trial: To establish whether the sensitivity of MR-hyperpolarized [1-13C]Pyruvate based MR-spectroscopy is high enough for future studies of surgical intervention versus cytotoxic treatment.	—

Measure

Time frame

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 ;Main Objective: Proof of concept study for application of hyperpolarized [1-13C]Pyruvate in magnetic resonance spectroscopy for early in vivo detection of therapeutic effects in treatment of pancreatic cancer;Secondary Objective: Secondary objectives of the trial: To establish whether the sensitivity of MR-hyperpolarized [1-13C]Pyruvate based MR-spectroscopy is high enough for future studies of surgical intervention versus cytotoxic treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): After subsequent 10 complete patient scanning's ;Timepoint(s) of evaluation of this end point: After completing all 15 hyperpolarization scanning's	—

Countries

Denmark

Contacts

Public ContactMR-Centre, Dept. clinical Medicine

Dept Clinical Medicine, Aarhus University

cl@clin.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026