Colorectal CancerPhase 2EXPLOSIVENCT01186263
Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy
A Phase 2 study testing MAA for diagnostic SPECT imaging and Diagnostic B20- SPECT imaging. in people with Colorectal Cancer and Liver Metastases, run by University of Magdeburg at 1 site in Germany.
Trial summary
The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres (SIR- spheres). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- MAA for diagnostic SPECT imaging and Diagnostic B20- SPECT imaging.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Aug 2013
- Phase
- Phase 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: between 18 and 85 years
- if female, postmenopausal or surgically sterilized
- liver metastases of a colorectal tumor in both liver lobes
- scheduled for therapy with 90Y SIR spheres for clinical reasons
- life expectancy longer than 6 months
- willing and able to undergo all study procedures
- having voluntarily provided written and fully informed consent
Who cannot join
- presenting with a contraindication to 90Y SIR spheres therapy
- variants of the arterial hepatic blood supply which interfere with the objectives of this study (e.g., variants of Michel)
- women who are pregnant, lactating or who are of childbearing potential
- patients being clinically unstable
- uncooperative, in the investigator's opinion
- any contraindication to SIRT treatment
Show all 11Show fewer
- any concomitant chemotherapy
- shunt to the lung >10%
- shunt to any extrahepatic organ (except the lung)
- having been previously enrolled in this study
- participating in another prospective clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Radiology and Nuclear Medicine
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: Exploratory Study to Assess the Predictive Value of 99mTc-labeled Albumin Spheres for the Intrahepatic Distribution of 90Y SIR Spheres in Patients With Liver Metastases of Colorectal Tumors
The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres (SIR- spheres).
Read the detailed description
Patients with metastases of colorectal tumors will be included into this study provided that they are scheduled for 90Y SIR spheres therapy for clinical reasons. Before 90Y SIR spheres therapy, patients will receive a diagnostic examination with injection of MAA (group A) or B20 (group B) into the common hepatic artery to rule out a relevant shunt volume to the lung or other extra-hepatic locations (e.g., stomach) as recommended by the manufacturer. After the diagnostic scan, therapy with SIR- spheres will be conducted in 2 separate sessions with selective injection of 90Y labeled SIR spheres into the right and left hepatic artery at two separate occasions (routine procedure at the University of Magdeburg, Germany). In addition, therapeutic sessions will include the selective injection of MAA or B20 into the right / left hepatic artery according to a predefined plan (either alone or as a mixture with the SIR spheres).The intra-hepatic distribution of 90Y labeled SIR spheres will be assessed using "Bremsstrahlen"- Single- Photon- Emission- Computed- Tomography (SPECT)- imaging, the distribution of MAA and B20 will be assessed using SPECT imaging.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- MAA for diagnostic SPECT imaging, Diagnostic B20- SPECT imaging.
- Keywords
- liver metastases, MAA, B20, SIR spheres, SPECT, intra-hepatic distribution
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAA for diagnostic SPECT imagingDrug
Also called TechneScan Lyo MAA
Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.
Diagnostic B20- SPECT imaging.Drug
Also called ROTOP HSA microspheres B20
Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.
| Study group | Role | What they receive |
|---|---|---|
| 99mTc- labeled albumin macroaggregates (MAA) | Experimental | Diagnostic MAA- SPECT- imaging. Receives: Drug: MAA for diagnostic SPECT imaging |
| 99mTc- labeled albumin microspheres (B20) | Experimental | Diagnostic B20- SPECT- imaging. Receives: Drug: Diagnostic B20- SPECT imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by Tc-99m MAA will be given by a blinded reader in categories by visual assessment (0-10%, >10-20%, >20-30%, …, >90-100%) (only patients who received Tc-99m MAA during evaluation.)
Measured: Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
Secondary outcomes (3)
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy
The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by B20 will be given by a blinded reader in categories by visual assessment (0-10%, >10-20%, >20-30%, …, >90-100%) (only patients who received Tc-99m B20 during evaluation.)
Measured: Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20.
elimination half-life calculated in [min] from the decay-corrected radioactivity concentration measured over the liver; % radioactivity trapped in the liver at the individual measuring time points (of total radioactivity measured over the liver in the first scan); percent lung shunt (percentage of liver activity leaking to the lung at the individual time points)
Measured: One day prior to SIRT
Adverse events as elicited upon indirect questioning.
Number of patients with adverse events (AEs), number of AEs per patient; descriptive listing of all AEs
Measured: At any visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical
- Responsible party
- Principal investigator, Jens Ricke, University of Magdeburg
- Investigators
- Jens Ricke, Prof. Dr., Principal investigator, University of Magdeburg, Faculty for Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186263
- Sponsor's protocol ID
- RAD050
- Other IDs
- 2008-005609-21, 2008
- Acronym
- EXPLOSIVE
- Status last verified
- Sep 2014
- First submitted
- 23 Jul 2010
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Assess the Predictive Value of 99mTc-labeled Albumin Spheres for the Intrahepatic Distribution of 90Y SIR Spheres in Patients With Liver Metastases of Colorectal Tumors
- ClinicalTrials.gov ID
- NCT01186263
- Acronym / sponsor ID
- EXPLOSIVE / RAD050
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- liver metastases, MAA, B20, SIR spheres, SPECT, intra-hepatic distribution
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- Sirtex Medical
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Aug 2010 (estimated)
- 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 purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres (SIR- spheres).
Detailed description
Patients with metastases of colorectal tumors will be included into this study provided that they are scheduled for 90Y SIR spheres therapy for clinical reasons. Before 90Y SIR spheres therapy, patients will receive a diagnostic examination with injection of MAA (group A) or B20 (group B) into the common hepatic artery to rule out a relevant shunt volume to the lung or other extra-hepatic locations (e.g., stomach) as recommended by the manufacturer. After the diagnostic scan, therapy with SIR- spheres will be conducted in 2 separate sessions with selective injection of 90Y labeled SIR spheres into the right and left hepatic artery at two separate occasions (routine procedure at the University of Magdeburg, Germany). In addition, therapeutic sessions will include the selective injection of MAA or B20 into the right / left hepatic artery according to a predefined plan (either alone or as a mixture with the SIR spheres).The intra-hepatic distribution of 90Y labeled SIR spheres will be assessed using "Bremsstrahlen"- Single- Photon- Emission- Computed- Tomography (SPECT)- imaging, the distribution of MAA and B20 will be assessed using SPECT imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 99mTc- labeled albumin macroaggregates (MAA) | Experimental | Drug: MAA for diagnostic SPECT imagingDiagnostic MAA- SPECT- imaging. |
| 99mTc- labeled albumin microspheres (B20) | Experimental | Drug: Diagnostic B20- SPECT imaging.Diagnostic B20- SPECT- imaging. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age: between 18 and 85 years
- if female, postmenopausal or surgically sterilized
- liver metastases of a colorectal tumor in both liver lobes
- scheduled for therapy with 90Y SIR spheres for clinical reasons
- life expectancy longer than 6 months
Key exclusion criteria (11 listed)
- presenting with a contraindication to 90Y SIR spheres therapy
- variants of the arterial hepatic blood supply which interfere with the objectives of this study (e.g., variants of Michel)
- women who are pregnant, lactating or who are of childbearing potential
- patients being clinically unstable
- uncooperative, in the investigator's opinion
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 |
|---|---|---|
| MAA for diagnostic SPECT imagingAlso: TechneScan Lyo MAAIntraarterial application of 5ml containing 500.000 particles with an activity of 150MBq. | Drug | 99mTc- labeled albumin macroaggregates (MAA) |
| Diagnostic B20- SPECT imaging.Also: ROTOP HSA microspheres B20Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq. | Drug | 99mTc- labeled albumin microspheres (B20) |
Primary outcome
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
Time frame: Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by Tc-99m MAA will be given by a blinded reader in categories by visual assessment (0-10%, >10-20%, >20-30%, …, >90-100%) (only patients who received Tc-99m MAA during evaluation.)
3 secondary outcomes
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy
Time frame: Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20.
Time frame: One day prior to SIRT
Adverse events as elicited upon indirect questioning.
Time frame: At any visit.
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 4 Sep 2014.
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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.
Jens Ricke, Prof. Dr. principal investigator
University of Magdeburg, Faculty for Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAA for diagnostic SPECT imaging and Diagnostic B20- SPECT imaging. in people with Colorectal Cancer and Liver Metastases, run by University of Magdeburg at 1 site in Germany.
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 7 inclusion and 11 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 4 Sep 2014. 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 Germany. 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 phase mean?
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?
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy (time frame: Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy). 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 4 Sep 2014.