Trial · NCT03291379
Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies
NCT03291379, Early phase 1, Completed, Boston Scientific Corporation; results first posted 2021-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies. Trials, record NCT03291379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03291379
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies
- NCT number
- NCT03291379
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Carcinoma, Hepatocellular, Metastatic Colorectal Cancer
- Interventions
- BTG-002814
- First posted
- 2017-09-25
- Last updated
- 2021-07-19
- Results first posted
- 2021-02-03
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Assess the Safety and Tolerability of Treatment With BTG-002814 | Continuously throughout the study totalling 9 weeks | Adverse events (AEs) related to treatment with BTG-002814 using the National Cancer Institute- Common Terminology Criteria for Adverse Events- Version 4.0 (NCI-CTCAE v4.0) |
| Primary | Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814 | pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery) | Pharmacokinetic (PK) analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive Cmax. |
| Primary | Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | Following surgical resection of tumour | PK analysis of participants resected liver tissue samples by liquid chromatography with tandem mass spectrometry to determine vandetanib concentrations at the centre, middle, and edge of the tumour, as well as in the normal tissue surrounding the tumour (1cm away). |
| Primary | Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814 | pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery) | PK analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive Tmax |
| Primary | Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814 | pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery) | PK analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive AUCEoS (area under the curve at end of study). |
| Primary | Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | Following surgical resection of tumour | PK analysis of participants resected liver tissue samples by liquid chromatography with tandem mass spectrometry to determine N-desmethyl vandetanib concentrations at the centre, middle, and edge of the tumour, as well as in the normal tissue surrounding the tumour (1cm away). |
| Secondary | Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT | 1 day after treatment | An automated thresholding and filtering algorithm was designed to allow the volume of delivered beads to be quantitatively determined for regions of interest (liver, registered sample, tumour, tumour dilated 1cm, tumour dilated 2cm) from the pre-surgical non-contrast CT scan and the PET/CT of the explanted liver samples following surgery. |
| Secondary | Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability | Post-surgery (tumour resection) | An evaluation of histopathological features in both malignant and non-malignant liver tissue from the surgical specimen was performed by microscopic examination. Sections of resected liver tissue was paraffin-embedded and Hematoxylin and Eosin (H\&E) slides were produced. The H\&E slides were scanned to produce 3D pathology models of tumour volume and compared to the 3D models generated from clinical imaging. This allowed the extent of tumour necrosis and viable tumour to be determined. |
| Secondary | Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes. | Post-surgery (tumour resection) | An evaluation of histopathological features in both malignant and non-malignant liver tissue from the surgical specimen was performed by microscopic examination. Sections of resected liver tissue was paraffin-embedded and Hematoxylin and Eosin (H\&E) slides were produced. The H\&E slides were scanned to produce 3D pathology models of tumour volume and compared to the 3D models generated from clinical imaging. This allowed any vascular changes to be determined. |
| Secondary | Assessment of Changes in Blood Flow on Dynamic Contrast-Enhanced (DCE) MRI Following Treatment With BTG-002814. The Following Parameters Will be Derived From DCE-MRI Images: Ktrans, Kep and Ve. | Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour | After acquisition of DCE-MRI liver sequences, tumour signal intensity curves were used to calculate tissue parameters describing tumour perfusion, blood flow and vascularity, before and following treatment with BTG 002814. Bland Altman analysis showed the variability between baseline and pre-treatment readings to be too high, so an interpretation of the changes in blood flow prior to surgery is unreliable. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Assess the Safety and Tolerability of Treatment With BTG-002814 | Continuously throughout the study totalling 9 weeks | Safety population - all participants treated with BTG-002814 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814 | pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery) | all participants treated with BTG-002814 | ng/mL | MEAN |
| PRIMARY | Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | Following surgical resection of tumour | Results were not available for 2 patients where sample was incorrectly prepared, or no sample was received. For patients with multiple tumours, only the treated tumours were sampled and analysed. The results for this outcome measure are reported by individual subject (where data was available) by each sample location (centre, middle, edge of the tumour or 1cm away from tumour) per row. | ng/mL | NUMBER |
| PRIMARY | Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814 | pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery) | all participants treated with BTG-002814 | hours | MEAN |
| PRIMARY | Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814 | pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery) | all participants treated with BTG-002814 | ng*h/mL | MEAN |
| PRIMARY | Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | Following surgical resection of tumour | Results were not available for 2 patients where sample was incorrectly prepared, or no sample was received. For patients with multiple tumours, only the treated tumours were sampled and analysed. The results for this outcome measure are reported by individual subject (where data was available), by each sample location (centre, middle, edge of the tumour, 1cm away from tumour) per row. | ng/mL | NUMBER |
| SECONDARY | Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT | 1 day after treatment | All 8 subjects treated with BTG-002814 were analysed, however, not all subjects have sampling of all regions (liver, registered sample, tumour, tumour dilated 1cm, tumour dilated 2cm) due to some samples not being able to be accurately processed and registered. The data for this outcome measure is reported by individual subject, for each sample region (where data is available) per row. | µL | NUMBER |
| SECONDARY | Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability | Post-surgery (tumour resection) | all participants treated with BTG-002814 | percentage of surgical specimen | MEDIAN |
| SECONDARY | Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes. | Post-surgery (tumour resection) | Count of Participants | NUMBER | |
| SECONDARY | Assessment of Changes in Blood Flow on Dynamic Contrast-Enhanced (DCE) MRI Following Treatment With BTG-002814. The Following Parameters Will be Derived From DCE-MRI Images: Ktrans, Kep and Ve. | Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group107
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Safety and Tolerability of Treatment With BTG-002814 | BTG-002814 | participants with treatment emergent Adverse Events (AEs) | 8 | Participants | |
| To Assess the Safety and Tolerability of Treatment With BTG-002814 | BTG-002814 | participants with treatment emergent Serious Adverse Events (SAEs) | 4 | Participants | |
| Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814 | BTG-002814 | Vandetanib Plasma Cmax | 24.3 | Standard Deviation 13.94 | ng/mL |
| Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814 | BTG-002814 | N-desmethyl Plasma Cmax | 0.6 | Standard Deviation 0.82 | ng/mL |
| Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | BTG-002814 | Subject 01: Vandetanib concentration centre of tumour | 404000 | ng/mL | |
| Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | BTG-002814 | Subject 01: Vandetanib concentration middle of tumour | 394000 | ng/mL | |
| Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | BTG-002814 | Subject 01: Vandetanib concentration edge of tumour | 327000 | ng/mL | |
| Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | BTG-002814 | Subject 01: Vandetanib concentration 1cm away from tumour | 10800 | ng/mL | |
| Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | BTG-002814 | Subject 03: Vandetanib concentration centre of tumour | 8510 | ng/mL | |
| Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | BTG-002814 | Subject 03: Vandetanib concentration middle of tumour | 11000 | ng/mL |
1 to 10 of 107Source ClinicalTrials.gov
See all 107 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BTG-002814 | 8 | |
| Overall Study | COMPLETED | BTG-002814 | 8 | |
| Overall Study | NOT COMPLETED | BTG-002814 | 0 |
Source ClinicalTrials.gov
Adverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | BTG-002814 | 3 | 8 | 5 |
| other | Cardiac signs and symptoms NEC | Cardiac disorders | BTG-002814 | 1 | 8 | 1 |
| other | Sinus bradycardia | Cardiac disorders | BTG-002814 | 2 | 8 | 2 |
| other | Tinnitus | Ear and labyrinth disorders | BTG-002814 | 2 | 8 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | BTG-002814 | 1 | 8 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | BTG-002814 | 8 | 8 | 19 |
| other | Constipation | Gastrointestinal disorders | BTG-002814 | 5 | 8 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | BTG-002814 | 1 | 8 | 1 |
| other | Dry mouth | Gastrointestinal disorders | BTG-002814 | 1 | 8 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | BTG-002814 | 5 | 8 | 8 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BTG-002814 | 1 | 8 |
| Total, other adverse events | BTG-002814 | 8 | 8 |
| Total, serious adverse events | BTG-002814 | 4 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31579027 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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