To determine the choline levels of FNH, HCA and HCC using proton Magnetic Resonance Spectroscopy (expressed as parts per million).
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatic and biliary neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Choline levels: Expressed as parts per million.
The number of parts per million is calculated by dividing the difference in
frequency (in hertz) of choline and water, by the operating frequency of the MR
imaging system (in hertz).
2. Histological outcome (obtained from patient's medical records)
3 Outcome of imaging modalities used to assess diagnosis (multiphase CT and
MR), only if histology is not obtained and imaging results are characteristic
and definite in the diagnosis of FNH, HCA or HCC.
Secondary outcome
not applicable
Background summary
Hepatocellular adenoma (HCA) and focal nodular hyperplasia (FNH) are benign
liver tumors. Hepatocellular carcinoma (HCC) is a malignant tumor of the
liver. The PET/CT scan with a choline radiopharmacon is used in the diagnostic
work-up of these liver lesions. Choline is an essential nutrient and is used in
the human body for the synthesis of phosphatidylcholine and sphingomyelin, two
phospholipids which are structural components of all human cell membranes.
According to recent study conducted at our center, the PET/CT scan with the
choline tracer shows no uptake in HCA, but surprisingly it does in FNH.
Malignant tumor cells are known to have rapid cell duplication and therefore
have a higher uptake of choline as a substrate for cell membranes. HCCs for
example show high uptake of the choline tracer and elevated choline levels on
Proton Magnetic Resonance Spectroscopy (MRS). With this imaging technique
accurate assessment of tissue compounts like choline can be non invasively
acquiered.
Study objective
To determine the choline levels of FNH, HCA and HCC using proton Magnetic
Resonance Spectroscopy (expressed as parts per million).
Study design
- Prospective observational diagnostic single center clinical study.
- The MRS will be evaluated by a radiologist blinded for patient history,
previous imaging results and histological outcome.
Study burden and risks
The proton MR Spectroscopy (1H-MRS) is an additional imaging modality performed
once and will take approximately 30-40 minutes. The MRS is a non-invasive,
non-ionizing examination, during which the participant will have to lie still
on his/her back in a MRI scanner. No contrast medium will be administered.
Participating in the study will require one extra visit to the hospital.
Participation has no direct advantage for the participant. Incidental findings
on the MRI scan will be reported to both the participant and their consulting
gastroenterologist or general practitioner. Patients are not delayed in
treatment for their disease. There will be little extra physical and
psychological discomfort associated with participation.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Affirmed diagnosis of FNH, HCA or HCC based on:
- Histopathological proof
- If no histological proof was obtained: results of imaging modalities characteristic for FNH, HCA or HCC. These characteristics of MR and CT imaging include:
* HCA: Hypervascular lesion in the arterial phase and signs of bleeding and/or fat within the lesion.
* FNH: Hypervascular lesion in the arterial phase, and the presence of a central scar.
* HCC: Hypervascular lesion in the arterial phase, followed by wash-out during the portal or late phase AND positive patient history for risk factors in HCC development including hepatitis B and C, haemochromatosis, alcohol abuses and cirrhosis OR elevated alpha fetoprotein 1.
2. Size of the lesion: > 2 cm.
3. 18 years of age or older.
4. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
1. Contraindications for MR imaging:
- Pacemaker, medicine pump, neurostimulator, claustrophobia, iron slivers in the eye, brace.
- Irremovable body piercing, iron particles in the body.
- Patients with extreme obesity (will not fit in the bore of the MRI)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35184.018.10 |