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NCT Number: NCT06355895

Liver Volume Variation Effect on SBRT Planning and Delivery for Upper Abdominal Malignancies

Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location status: Recruiting

Location contact

Brieanna Marino

CONTACT

Samantha Demko

CONTACT

Susannah Ellsworth, MD

PRINCIPAL_INVESTIGATOR

About this study

Stereotactic body radiotherapy (SBRT) is an integral tool in the management of thoracic and upper abdominal malignancies. SBRT delivers ablative radiation doses in a limited number of fractions (thereby reducing interruptions in systemic therapy) with emerging evidence for feasibility and local control benefit. Effective SBRT delivery requires high-precision target localization that accounts for positional variations in both the target and nearby organs at risk (OAR). An absolute requirement for SBRT is accurate target localization and motion management, particularly when treating targets in the chest and abdomen, which are subject to respiratory motion as well as changes in configuration due to deformation of hollow viscera. To ensure adequate targeting, various technical solutions are available, including motion management approaches such as four-dimensional computed tomography (4D-CT), abdominal compression, respiratory gating, and breath hold, as well as daily image-guided radiotherapy (IGRT) techniques such as cone beam computed tomography (CBCT), which facilitate precise daily target verification and minimization of the planning target volumes (PTVs). While the effects of respiratory motion on patient positioning during upper abdominal SBRT are relatively well understood, little is known about the effect of liver volume changes on radiotherapy (RT) dose delivery, despite the potential for morphological variations in the liver to affect patient setup and radiation dose distribution in real time. The liver is a dynamic organ with various functions including glycogen storage, carbohydrate (carb)/lipid/protein metabolism, bile secretion, synthesis of plasma proteins, and metabolism of various substances including steroid hormones and ingested toxins. Liver function is affected by fasting and feeding cycles, with an intrinsic circadian rhythm first observed in animal studies. This trial proposes to affect liver volume to ultimately and positively affect treatment planning for abdominal SBRT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have primary upper abdominal (pancreatic, bile duct, liver) cancer or upper abdominal metastases (liver, adrenal, upper abdominal lymph nodes) planned to undergo SBRT.

Exclusion criteria

  • Had prior Radiation Therapy to the liver
  • Contraindication to receipt of iodinated IV contrast for CT (such as renal insufficiency or allergy that cannot be overcome by premedication)
  • Pregnancy/lactation OR woman of childbearing potential who is unable or unwilling to use adequate contraception during Radiation Therapy.
  • Inability to fast.

Treatment and study plan

Standardized high-carbohydrate meal

Dietary Supplement

8 ounces of Ensure® nutritional protein shake or a similar meal

Primary outcomes

  1. Diurnal Difference in Liver Volumes

    Time frame: At baseline and at 4 hours post intervention

    Percentage diurnal difference in total liver volumes (change in liver volume), as measured by Stereotactic Body Radiation Therapy (SBRT) planning software.

Secondary outcomes

  1. Difference in total liver volume

    Time frame: At baseline and at 1 hour post intervention

    Percentage difference in total liver volume (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

  2. Percentage diurnal difference in liver mean dose at V5 Gy

    Time frame: At baseline and at 1 hour post intervention

    Percentage diurnal difference in liver mean dose at V5 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

  3. Percentage diurnal difference in liver mean dose at V15Gy

    Time frame: At baseline and at 1 hour post intervention

    Percentage diurnal difference in liver mean dose at V15 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

  4. Difference in liver mean dose at V15 Gy

    Time frame: At baseline and at 1 hour post intervention

    Percentage difference in liver mean dose, V5 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

  5. Difference in liver dose at V15 Gy

    Time frame: At baseline and at 1 hour post intervention

    Percentage difference in liver mean dose at V15 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

Study contacts

Contact information is provided by the study sponsor or research team.

Brieanna Marino, MS

CONTACT

[email protected]

412-647-8258

Samantha Demko, BSN

CONTACT

[email protected]

412-623-1400

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • American College of Radiation Oncology

Registry information

Official study title

The Effect of Liver Volume Variation on Stereotactic Body Radiation Therapy (SBRT) Planning and Delivery for Upper Abdominal Malignancies

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 10, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.