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MR-HYPERPOLARISATION SCANNING WITH HYPERPOLARISED PYRUVATE (13C) IN PANCREATIC CANCER PATIENTS – A FEASIBILITY STUDY
EU CTIS ID: 2024-517358-86-00
What this study is testing
To optimise the MR-hyperpolarisation scanning technique in patients using a dose of 13C-Pyruvate established as safe in previous phase I/II-studies. To obtain baseline data on 13C-Pyruvate MR-hyperpolarisation signals in selected anatomical sites including tumorous pancreas, non-tumorous pancreas, liver metastases and normal liver. To confirm safety and feasibility of infusion of 13C-Pyruvate in patients with pancreatic cancer. To explore correlations between 13C-Pyruvate MR-hyperpolarisation signals and evidence of clinical response to chemotherapy to be tested in further phase II-studies.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with inoperable (metastatic, locally advanced or localised)or relapsedhistologically or cytologically verified pancreatic adenocarcinoma
- Scheduled for first-line palliative chemotherapy of any type or having received at least 4 cycles of chemotherapy
- At least 18 years of age
- WHO performance status 0-2
- 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
- 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.
You likely can't join if
- Contraindications to contrast enhanced MRI
- Predicted remaining survival <3 months
- Contraindication to contrast enhanced CT
- Not able or willing to receive chemotherapy
- Patients not willing to participate
- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia or cardiac events
See the full eligibility criteria
- Patients with inoperable (metastatic, locally advanced or localised)or relapsedhistologically or cytologically verified pancreatic adenocarcinoma
- Scheduled for first-line palliative chemotherapy of any type or having received at least 4 cycles of chemotherapy
- At least 18 years of age
- WHO performance status 0-2
- 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
- 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.
- Danish speaking
- Able and willing to comply after informed consent
- Contraindications to contrast enhanced MRI
- Predicted remaining survival <3 months
- Contraindication to contrast enhanced CT
- Not able or willing to receive chemotherapy
- Patients not willing to participate
- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia or cardiac events
- Previous or current radiotherapy or chemotherapy
- History of acute or chronic pancreatitis
- Acute or chronic liver disease incl. cirrhosis
- Intolerant to Pyruvate
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.