Pyruvic acid for Pancreatic adenocarcinoma | Pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Patients with inoperable (metastatic, locally advanced or localised)or relapsedhistologically or cytologically verified pancreatic adenocarcinoma"}
• {"criterion_text":"- Scheduled for first-line palliative chemotherapy of any type or having received at least 4 cycles of chemotherapy"}
• {"criterion_text":"- At least 18 years of age"}
• {"criterion_text":"- WHO performance status 0-2"}
• {"criterion_text":"- Adequate hematologic and organ function, i.e. ANC at least 1.500/uL Platlet count >100/uL 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"}
• {"criterion_text":"- Women who are not postmenopausal or surgically sterile must have a negative serum or urin pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device. If the partner is non fertile or the patient has no sexual activities, this is also accepted."}
• {"criterion_text":"- Danish speaking"}
• {"criterion_text":"- Able and willing to comply after informed consent"}

Exclusion criteria

• {"criterion_text":"- Contraindications to contrast enhanced MRI"}
• {"criterion_text":"- Predicted remaining survival <3 months"}
• {"criterion_text":"- Contraindication to contrast enhanced CT"}
• {"criterion_text":"- Not able or willing to receive chemotherapy"}
• {"criterion_text":"- Patients not willing to participate"}
• {"criterion_text":"- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia or cardiac events"}
• {"criterion_text":"- Previous or current radiotherapy or chemotherapy"}
• {"criterion_text":"- History of acute or chronic pancreatitis"}
• {"criterion_text":"- Acute or chronic liver disease incl. cirrhosis"}
• {"criterion_text":"- Intolerant to Pyruvate"}

Primary endpoints

• {"endpoint_text":"- C13-Pyruvate spectroscopy imaging generates spectroscopic parameters (quantitative data for lactate, pyruvate, arginine and HCO3-). These will be projected 07-07-22 Projektbeskrivelse: MR-hyperpolarization 8. Version. Page 25 into a high-resolution anatomical image. The quantitative numerical data will be given as ratios, e.g. lactate/pyruvate-ratio, which gives us the possibility to perform comparisons between non-tumor vs. tumor tissue and pre-chemo vs. post-chemo.","definition_or_measurement_approach":"Spectroscopic parameters (quantitative data for lactate, pyruvate, arginine and HCO3-) obtained from C13-pyruvate spectroscopy imaging, projected into high-resolution anatomical images; quantitative data reported as ratios (e.g. lactate/pyruvate) for comparisons between non-tumor vs. tumor tissue and pre- vs. post-chemotherapy."}

Denmark

Earliest CTIS Part Ii Submission Date

06-09-2024

Latest Decision Or Authorization Date

25-09-2025

Processing Time Days

384

Number Of Sites

1

Number Of Participants

16

Primary sponsor

Full Name

Aarhus Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Educational Institution"}