Contrast-Enhanced Ultrasound for Bile Duct Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Thomas Jefferson University

Disqualifiers: Pregnancy, Cerebral hemorrhage, Hypersensitivity, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial tests whether contrast-enhanced ultrasound can predict the response of bile duct cancer to targeted radiotherapy (radioembolization treatment). Contrast-enhanced ultrasound uses gas microbubbles that may provide enhancement on ultrasound. It is also possible to pop these microbubbles using ultrasound imaging. Tumors that experience popping of these microbubbles may be easier to kill with radiotherapies. Therefore, this trial may also help doctors see if ultrasound-triggered microbubble popping can improve bile duct cancer response to radiotherapy. Another purpose of this trial is to test if the pressure inside the tumor estimated through ultrasound can be used to predict the tumor response to radiotherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Perflutren Protein-Type A Microspheres, Optison, Perflutren Protein-Type A Microspheres, Radioembolization Treatment, Selective Internal Radiotherapy (SIRT), Y-90 Treatment, Radioembolization using Yttrium-90 (90Y)–labeled microspheres for bile duct cancer?

Research shows that Selective Internal Radiotherapy (SIRT) with Yttrium-90 (Y-90) microspheres has been effective in treating various liver cancers, including intrahepatic cholangiocarcinoma (a type of bile duct cancer), by delivering targeted radiation to tumors while sparing healthy liver tissue.

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Is Yttrium-90 treatment generally safe for humans?

Yttrium-90 (Y-90) treatment, also known as Selective Internal Radiation Therapy (SIRT) or radioembolization, has been used safely in treating various liver cancers. While it delivers high doses of radiation to tumors, it minimizes exposure to healthy liver tissue, though there can be complications like unintended radiation to nearby areas such as the gallbladder.

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How is the Radioembolization Treatment for bile duct cancer different from other treatments?

Radioembolization Treatment, also known as Selective Internal Radiotherapy (SIRT), is unique because it delivers high doses of radiation directly to the tumor in the liver using tiny radioactive beads (Yttrium-90 microspheres), minimizing exposure to healthy liver tissue. This targeted approach is different from traditional treatments that may affect more of the surrounding healthy tissue.

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Eligibility Criteria

This trial is for adults with untreated intrahepatic cholangiocarcinoma (bile duct cancer) that's larger than 1 cm but small enough to be seen in a 3D ultrasound. Participants must be medically stable and not pregnant if female of child-bearing age. Exclusions include recent cerebral hemorrhage, pregnancy, high bilirubin levels, allergy to perflutren or albumin, congenital heart defects, severe lung conditions.

Inclusion Criteria

I am of childbearing age and have a negative pregnancy test before each ultrasound.

I am 18 years old or older.

Have signed Informed Consent to participate in the study

Exclusion Criteria

I have had a recent brain bleed.

I was born with a heart defect.

Patients with known hypersensitivity to perflutren

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Assessment

Patients receive perflutren protein-type A microspheres IV and undergo ultrasound 1 month before TARE

1 month

1 visit (in-person)

Treatment

Patients undergo transarterial radioembolization (TARE) and receive ultrasound assessments at 1-4 hours, 1 week, and 2 weeks post-TARE

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments up to 6 months post-TARE

6 months

Multiple visits (in-person)

Participant Groups

The study tests if contrast-enhanced ultrasound can predict how well bile duct cancer responds to radioembolization treatment. It involves using gas microbubbles in the ultrasound which may pop and potentially make tumors more susceptible to radiotherapy. The trial also examines whether tumor pressure measured by ultrasound predicts treatment response.

Group I: Diagnostic (perflutren protein-type A microspheres, CEUS) Experimental Treatment 2 Interventions

Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo ultrasound at 1 month before TARE, 1-4 hours, 1 week, and 2 weeks post-TARE.

Radioembolization Treatment is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Radioembolization for:

• Unresectable intrahepatic cholangiocarcinoma
• Locally advanced intrahepatic cholangiocarcinoma

🇺🇸 Approved in United States as Radioembolization for:

• Unresectable intrahepatic cholangiocarcinoma
• Locally advanced intrahepatic cholangiocarcinoma
• Metastatic liver disease

🇨🇦 Approved in Canada as Radioembolization for:

• Unresectable intrahepatic cholangiocarcinoma
• Locally advanced intrahepatic cholangiocarcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia, PA

Who Is Running the Clinical Trial?

Thomas Jefferson University Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Yttrium-90 (Y-90) Resin Microsphere Therapy for Patients with Unresectable Hepatocellular Carcinoma: a Single-Center Experience. [2019] Selective intraarterial radionuclide therapy (SIRT) with yttrium-90 (Y-90) resin microspheres presently has successful results in primary or metastatic inoperable liver tumors. This procedure, which is also known as radioembolisation, delivers high doses of radiation selectively to hepatic tumors while minimum healthy liver exposure. The aim of this study was to present our clinical experience of radiomicrosphere therapy for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

2. United States pubmed.ncbi.nlm.nih.gov

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. [2022] Selective internal radiotherapy (SIRT) with yttrium-90 ((90)Y) resin microspheres can improve the clinical outcomes for selected patients with inoperable liver cancer. This technique involves intra-arterial delivery of β-emitting microspheres into hepatocellular carcinomas or liver metastases while sparing uninvolved structures. Its unique mode of action, including both (90)Y brachytherapy and embolization of neoplastic microvasculature, necessitates activity planning methods specific to SIRT.

3. Serbia pubmed.ncbi.nlm.nih.gov

Selective intraarterial radionuclide therapy with Yttrium-90 (Y-90) microspheres for hepatic neuroendocrine metastases: initial experience at a single center. [2019] Selective intraarterial radionuclide therapy (SIRT) with Yttrium-90 (Y-90) microspheres is also known as radioembolization and delivers high doses of radiation to hepatic tumors with minimum healthy liver exposure. The aim of this study was to present our preliminary experience in the role of liver directed radiotherapy with Y-90 microspheres for the treatment of unresectable hepatic metastases from neuroendocrine tumors (NET).

4. United States pubmed.ncbi.nlm.nih.gov

Is there a role for Ytrrium-90 in the treatment of unresectable and metastatic intrahepatic cholangiocarcinoma? [2019] Selective internal radiation therapy (SIRT) with Ytrrium-90 (Y-90) has been used to treat hepatic malignancies with success. This study focuses on the efficacy and safety of Y-90 in the treatment of unresectable and metastatic intrahepatic cholangiocarcinoma (ICC).

5. United States pubmed.ncbi.nlm.nih.gov

Selective internal radiotherapy (SIRT) of hepatic tumors: how to deal with the cystic artery. [2016] Selective internal radiotherapy (SIRT) with the beta emitter yttrium-90 (Y90) is a rapidly developing therapy option for unresectable liver malignancies. Nontarget irradiation of the gallbladder is a complication of SIRT. Thus, we aimed to assess different strategies to avoid infusion of Y90 into the cystic artery (CA).

6. China pubmed.ncbi.nlm.nih.gov

Selective internal radiation therapy using yttrium-90 resin microspheres in patients with unresectable hepatocellular carcinoma: a retrospective study. [2022] Selective internal radiation therapy (SIRT) with yttrium-90 resin (Y-90 resin) microspheres has been used as a locoregional therapy for patients with unresectable hepatocellular carcinoma (HCC). We examined patient and disease characteristics that might affect survival after Y-90 resin, as well as treatment tolerability.

7. Italy pubmed.ncbi.nlm.nih.gov

Yttrium-90 (Y-90) resin microsphere therapy for patients with unresectable hepatocellular carcinoma. Identification of successful treatment response predictors and patient selection. [2022] Selective intraarterial radionuclide therapy (SIRT) with Yttrium-90 (Y-90) resin microspheres has been applied for hepatocellular carcinoma (HCC) lately. The aim of this study is to present our clinical experience of radiomicrosphere therapy in the treatment of unresectable HCC and determine the proper cases who could benefit from this therapy according to response results yielded by initial staging and control imaging modalities.