What side effects are associated with this type of intervention?

Common treatments for pelvic cancer, such as chemotherapy with agents like carboplatin, paclitaxel, and cisplatin, and radiation therapy, have several known side effects. Chemotherapy can cause myelosuppression, leading to anemia, neutropenia, and thrombocytopenia, as well as gastrointestinal symptoms like nausea, vomiting, and diarrhea. Other side effects include neuropathy, fatigue, and hair loss. Radiation therapy can cause local side effects such as skin irritation, fatigue, and gastrointestinal symptoms, including diarrhea and abdominal pain. When IV contrast is used during CBCT, additional side effects may include allergic reactions, nephrotoxicity, and contrast-induced nephropathy.

What prior FDA approvals exist?

FDA-approved treatments for pelvic cancers, such as ovarian, fallopian tube, and peritoneal cancers, often involve chemotherapy regimens like carboplatin and paclitaxel. These treatments can be administered in conventional or dose-dense schedules. Additionally, bevacizumab, an angiogenesis inhibitor, is sometimes added to these regimens to improve outcomes. While the use of IV contrast in CBCT is primarily for enhancing imaging during radiotherapy, it is not a direct treatment for cancer but rather a supportive diagnostic tool to improve the precision of radiation therapy.

What other types of research exist?

One promising alternative to IV contrast for enhancing visibility during CBCT in pelvic cancer patients is the use of blood pool contrast agents, such as an emulsion of Ethiodol and Pluronic. This agent has shown prolonged vascular visualization, which could be beneficial for detailed imaging. Additionally, optical molecular imaging techniques, such as optical coherence tomography and confocal microendoscopy, coupled with targeted contrast agents, offer advanced imaging capabilities that could be adapted for pelvic cancer.

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Contrast-Enhanced CBCT for Abdominal/Pelvic Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for pelvic cancer include chemotherapy, radiation therapy, and surgery. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to target and destroy cancerous tissues. Surgery involves the physical removal of tumors. Intravenous (IV) contrast is often used during imaging techniques like Cone Beam Computed Tomography (CBCT) to enhance the visibility of organs and blood vessels, which is crucial for accurate treatment planning and monitoring. For pelvic cancer patients, understanding these mechanisms helps in comprehending how each treatment targets the cancer, the importance of precise imaging for effective treatment, and the potential side effects they may experience.

Phase < 1

Waitlist Available

Led By David Horowitz, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3

Subject requiring image-guided external beam radiotherapy to abdominal or pelvic tumor with cone beam CT deemed clinically necessary by the treating physician

Must not have

Chronic renal insufficiency, stage IV or V

Presence of single kidney or transplanted kidney

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new method can improve imaging for patients with abdominal and pelvic tumors. The goal is to help doctors target the tumors more accurately.

Who is the study for?

This trial is for adults over 18 needing image-guided radiotherapy for abdominal or pelvic tumors, with proper kidney function (creatinine <1.9 mg/dL), no recent IV contrast use, and no severe allergies to CT contrast media. Pregnant or nursing individuals, those with advanced kidney disease, single/transplanted kidneys, or inability to fast are excluded.

What is being tested?

The study tests if using IV contrast during CBCT scans improves imaging for guiding radiation therapy in treating abdominal/pelvic tumors. Participants will receive a saline solution and Omnipaque injection before undergoing enhanced CBCT as part of their treatment planning.

What are the potential side effects?

Potential side effects include allergic reactions to the IV contrast used in the scan (Omnipaque), such as itching or rash; kidney function changes due to the contrast agent; and discomfort from fasting required before procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may not be able to do heavy physical work.

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My doctor says I need special radiation for my abdominal or pelvic tumor.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely reduced.

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I have only one kidney or a transplanted kidney.

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I am currently experiencing acute kidney failure.

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I cannot receive IV contrast due to fluid overload.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blinded Match between contrast and non-contrast enhanced CBCT

Physician Survey of attitude about the utility of contrast-enhanced cone beam CT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contrast Enhanced Cone Beam CTExperimental Treatment4 Interventions

60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

0.9% Saline

2011

Completed Phase 4

~32970

Radiation Therapy

2017

Completed Phase 3

~7250

Cone Beam CT

2009

N/A

~160

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pelvic cancer include chemotherapy, radiation therapy, and surgery. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to target and destroy cancerous tissues. Surgery involves the physical removal of tumors. Intravenous (IV) contrast is often used during imaging techniques like Cone Beam Computed Tomography (CBCT) to enhance the visibility of organs and blood vessels, which is crucial for accurate treatment planning and monitoring. For pelvic cancer patients, understanding these mechanisms helps in comprehending how each treatment targets the cancer, the importance of precise imaging for effective treatment, and the potential side effects they may experience.

The current role of radiotherapy in the management of ovarian cancer.