Clinical validation of a fractional administration device for holmium-166 microspheres during selective internal radiation therapy in patients with liver tumours

Clinical validation of a fractional administration device for holmium-166 microspheres during selective internal radiation therapy in patients with liver tumours - CONTROL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50197

Enrollment

Registered

2021-11-30

Start date

2022-06-30

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

liver cancer liver metastases

Interventions

Holmium-166 SIRT as per usual, with patient positioned in MRI scanner. Injection of microspheres will be done with a novel injection device.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of hepatocellular carcinoma or liver metastases originating from colorectal cancer 2. At least one lesion of 10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT 3. Patient is eligible for SIRT as determined by the tumour board (in Dutch: MDO) 4. Patient has a life expectancy of 12 weeks or longer 5. Patient has a WHO performance score of 0-2

Exclusion criteria

Exclusion criteria: 1. Significant extrahepatic disease (2x sum of diameters of lesions outside the liver > sum of lesions inside the liver) 2. Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment 3. Serum bilirubin > 2.0 x the upper limit of normal 4. ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal 5. Glomerular filtration rate (GFR-MDRD) 150 kg (because of maximum table load) 15. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) 16. Lung shunt > 30 Gy, as calculated using scout dose holmium-166 SPECT/CT 17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.

Design outcomes

Primary

Measure	Time frame
To determine technical performance and accuracy of a novel injection device for SIRT. Additionally, the safety of the device will be assessed.	—

Secondary

Measure	Time frame
To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response. To investigate the potential added value of gated 166Ho-SPECT/CT compared to conventional 166Ho-SPECT/CT . To investigate the added value of a novel reconstruction algorithm for cone-beam CT (CAVAREC) that compensates for motion during CT acquisition. Local response evaluation at 3 months after treatment through contrast-enhanced MRI and/or contrast-enhanced CT, according to mRECIST/RECIST 1.1 criteria (depending on tumour type).	—

Measure

Time frame

To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response. To investigate the potential added value of gated 166Ho-SPECT/CT compared to conventional 166Ho-SPECT/CT . To investigate the added value of a novel reconstruction algorithm for cone-beam CT (CAVAREC) that compensates for motion during CT acquisition. Local response evaluation at 3 months after treatment through contrast-enhanced MRI and/or contrast-enhanced CT, according to mRECIST/RECIST 1.1 criteria (depending on tumour type).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)