A Phase 2 interventional study of Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere) in Colorectal Neoplasms, Neuroendocrine Tumors and Cholangiocarcinoma, sponsored by Nicholas Fidelman, MD. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-01.
Sponsored by Nicholas Fidelman, MD · Phase 2, Interventional, and Treatment
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This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).
6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.
This study's enrollment of 42 is below the median of 76 across 4,802 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Nicholas Fidelman, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery
Number of Participants With Adverse Events
Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.
Time frame: 6 months
Radiographic Response
Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.
Time frame: 6 months after treatment
Between May 2010 and October 2013, 42 adult patients with liver-dominant metastaticd colorectal or neuroendocrine cancer to the liver, or intrahepatic cholangiocarcinoma were enrolled in a prospective single-institution pilot study.
| Milestone | Yttrium-90 Radioembolization |
|---|---|
| Started | 42 |
| Completed | 42 |
| Not completed | 0 |
Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.
| participants | Yttrium-90 Radioembolization |
|---|---|
| Number of Participants With Adverse Events | 42 |
Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.
| participants | Colorectal - Yttrium-90 Radioembolization | Neuroendocrine - Yttrium-90 Radioembolization | Other Tumors - Yttrium-90 Radioembolization |
|---|---|---|---|
| Complete Response (CR) | 0 | 0 | 0 |
| Partial Response (PR) | 4 | 7 | 1 |
| Stable Disease (SD) | 12 | 4 | 6 |
| Progressive Disease (PD) | 4 | 0 | 3 |
Collected over 6 months after treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Yttrium-90 Liver Radioembolization | — | 3/42 (7.1%) | 42/42 (100%) |
| Event | Yttrium-90 Liver Radioembolization |
|---|---|
| hospitalization for carcinoid crisisBlood and lymphatic system disorders | 1/11 |
| VomitingGastrointestinal disorders | 1/42 |
| gastric ulcerGastrointestinal disorders | 1/42 |
| Event | Yttrium-90 Liver Radioembolization |
|---|---|
| FatigueGeneral disorders | 34/42 |
| ASTMetabolism and nutrition disorders | 24/42 |
| NauseaGeneral disorders | 20/42 |
| Abdominal painGeneral disorders | 19/42 |
| AnorexiaGastrointestinal disorders | 18/42 |
| AlbuminemiaMetabolism and nutrition disorders | 15/42 |
| ALTMetabolism and nutrition disorders | 14/42 |
| BilirubinMetabolism and nutrition disorders | 9/42 |
| VomitingGastrointestinal disorders | 8/42 |
| SweatingGeneral disorders | 7/42 |
per protocol
| Age, Continuous(years) | Yttrium-90 Radioembolization |
|---|---|
| Median | 61 (35 to 85) |
| Sex: Female, Male(Participants) | Yttrium-90 Radioembolization |
|---|---|
| Female | 11 |
| Male | 31 |
| Region of Enrollment(participants) | Yttrium-90 Radioembolization |
|---|---|
| United States | 42 |
No study locations are listed for this record.
The record gives a start of May 2010, a primary completion of Oct 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2014, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Nicholas Fidelman, MD