Colorectal NeoplasmsPhase 1/2NCT03477019
Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
A Phase 1/2 study testing SonoVue and Focused Ultrasound in people with Colorectal Neoplasms and Breast Neoplasms, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The aim of this clinical trial is to investigate whether the therapeutic response of chemotherapy can be improved by focused ultrasound and microbubbles. Patients with liver metastases from breast cancer and colorectal cancer will be included. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Neoplasms, Breast Neoplasms
- What is being tested?
- SonoVue and Focused Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- 12 Nov 2018to 31 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified breast carcinoma or colorectal carcinoma
- 2 or multiple liver metastases
- considered eligible by a consulting oncologist for first line treatment with chemotherapy in the group of taxanes (patients with breast cancer) or the combination regimen FOLFIRI (patients with colorectal carcinoma)
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
Who cannot join
- Known contraindications for ultrasound contrast-enhancement agent Sonovue® (Bracco)
- Hematological bleeding status before experimental treatment: Hb < 8g/dL, trc < 80 x109/l, APTT˃ 45s, INR ˃ 1,5
- Considered eligible for surgical removal of liver metastases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Carcinoma- a Randomized Trial
The aim of this clinical trial is to investigate whether the therapeutic response of chemotherapy can be improved by focused ultrasound and microbubbles. Patients with liver metastases from breast cancer and colorectal cancer will be included. Computer Tomography (CT) will be performed as a baseline scan before treatment start. Two metastases in each patients liver will be preselected and randomized to either "target lesion" to be treated or "control lesion" to serve as internal control. The patients will receive conventional treatment with chemotherapy according to national guidelines. After intravenous chemotherapy infusion the patients will receive the experimental treatment. The target lesion will get focused ultrasound (FUS). Simultaneously repeated bolus-doses of microbubbles will be administered intravenously. The investigators will measure the difference in response between FUS- treated and -untreated lesions on the post-treatment CT scan.
- Conditions
- Colorectal Neoplasms, Breast Neoplasms
- Being tested
- SonoVue, Focused Ultrasound
- Keywords
- Contrast Agent BR, SonoVue, Ultrasonic Therapy, Neoplasm Metastasis, Liver, Microbubbles
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoVueDrug
consists of microbubbles containing sulfur hexafluoride stabilized by phospholipids.
Bolus doses à 1,0ml administered every 3.5 minutes , repeated 9 times. Total duration of treatment: 31,5 minutes. This treatment will be repeated maximally 4 times at 2 or 3 week intervals, depending on the patient's diagonse and treatment protocol.
Focused UltrasoundProcedure or surgery
ultrasound pulses will be generated by a clinically approved ultrasound skanner and probe.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer target lesion | Experimental | This arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for breast cancer. Receives: Drug: SonoVue; Procedure: Focused Ultrasound |
| Breast cancer control lesion | Other | This arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously. Receives: Drug: SonoVue |
| Colorectal cancer target lesion | Experimental | This arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for colorectal cancer. Receives: Drug: SonoVue; Procedure: Focused Ultrasound |
| Colorectal cancer control lesion | Other | This arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously. Receives: Drug: SonoVue |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in measured response between treated and untreated lesions
Response is measured in change in size of the treated metastases.
Measured: From baseline examination CT to response evaluation CT: 10-12 weeks
Secondary outcomes (1)
Occurrence of adverse effects
questionnaire 'Common toxicity criteria'
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start12 Nov 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two liver metastases in every patient are preselected on baseline computer tomography. These will be randomized to either 1) target lesion to be treated or 2) control lesion. Difference in response (pre- and post-treatment measure) between treated lesions and control lesions will be the primary outcome of the trial.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arne Solberg, PhD, MD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477019
- Sponsor's protocol ID
- 2018/13
- Other IDs
- 2018-002814-11, 2018
- Status last verified
- Jan 2023
- First submitted
- 19 Mar 2018
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes.Individual participant data that underlie the results reported in this article, after deidentification(text, tables, figures, and appendices). Protocol can be shared beginning 3 months and ending 5 years following article publication. Interested researchers who provide a reasonable, sound proposal are encouraged to direct this to the first author.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Carcinoma- a Randomized Trial
- ClinicalTrials.gov ID
- NCT03477019
- Acronym / sponsor ID
- 2018/13
- Conditions
- Colorectal Neoplasms, Breast Neoplasms
- Keywords
- Contrast Agent BR, SonoVue, Ultrasonic Therapy, Neoplasm Metastasis, Liver, Microbubbles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to investigate whether the therapeutic response of chemotherapy can be improved by focused ultrasound and microbubbles. Patients with liver metastases from breast cancer and colorectal cancer will be included. Computer Tomography (CT) will be performed as a baseline scan before treatment start. Two metastases in each patients liver will be preselected and randomized to either "target lesion" to be treated or "control lesion" to serve as internal control. The patients will receive conventional treatment with chemotherapy according to national guidelines. After intravenous chemotherapy infusion the patients will receive the experimental treatment. The target lesion will get focused ultrasound (FUS). Simultaneously repeated bolus-doses of microbubbles will be administered intravenously. The investigators will measure the difference in response between FUS- treated and -untreated lesions on the post-treatment CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two liver metastases in every patient are preselected on baseline computer tomography. These will be randomized to either 1) target lesion to be treated or 2) control lesion. Difference in response (pre- and post-treatment measure) between treated lesions and control lesions will be the primary outcome of the trial.
| Arm | Type | Receives |
|---|---|---|
| Breast cancer target lesion | Experimental | Drug: SonoVue, Procedure: Focused UltrasoundThis arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for breast cancer. |
| Breast cancer control lesion | Other | Drug: SonoVueThis arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously. |
| Colorectal cancer target lesion | Experimental | Drug: SonoVue, Procedure: Focused UltrasoundThis arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for colorectal cancer. |
| Colorectal cancer control lesion | Other | Drug: SonoVueThis arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically verified breast carcinoma or colorectal carcinoma
- 2 or multiple liver metastases
- considered eligible by a consulting oncologist for first line treatment with chemotherapy in the group of taxanes (patients with breast cancer) or the combination regimen FOLFIRI (patients with colorectal carcinoma)
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
Key exclusion criteria (4 listed)
- Known contraindications for ultrasound contrast-enhancement agent Sonovue® (Bracco)
- Hematological bleeding status before experimental treatment: Hb < 8g/dL, trc < 80 x109/l, APTT˃ 45s, INR ˃ 1,5
- Considered eligible for surgical removal of liver metastases
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonoVueconsists of microbubbles containing sulfur hexafluoride stabilized by phospholipids. Bolus doses à 1,0ml administered every 3.5 minutes , repeated 9 times. Total duration of treatment: 31,5 minutes. This treatment will be repeated maximally 4 times at 2 or 3 week intervals, depending on the patient's diagonse and treatment protocol. | Drug | Breast cancer control lesion, Breast cancer target lesion, Colorectal cancer control lesion, Colorectal cancer target lesion |
| Focused Ultrasoundultrasound pulses will be generated by a clinically approved ultrasound skanner and probe. | Procedure or surgery | Breast cancer target lesion, Colorectal cancer target lesion |
Primary outcome
difference in measured response between treated and untreated lesions
Time frame: From baseline examination CT to response evaluation CT: 10-12 weeks
Response is measured in change in size of the treated metastases.
1 secondary outcome
Occurrence of adverse effects
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: Undecided. Yes.Individual participant data that underlie the results reported in this article, after deidentification(text, tables, figures, and appendices). Protocol can be shared beginning 3 months and ending 5 years following article publication. Interested researchers who provide a reasonable, sound proposal are encouraged to direct this to the first author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Solberg, PhD, MD study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SonoVue and Focused Ultrasound in people with Colorectal Neoplasms and Breast Neoplasms, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in measured response between treated and untreated lesions (time frame: From baseline examination CT to response evaluation CT: 10-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.