A Phase I Therapeutic Dose Escalation Study using Percutaneous Image-Guided Navigation for High Dose Rate Brachyablation of Primary Liver Lesions

Study ID
STU 102014-018

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Patrick Brooks
214/645-2250
Patrick.Brooks@UTSouthwestern.edu

Principal Investigator
Michael Folkert, M.D., Ph.D.

Summary

This study is an investigation into dose escalation with image-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions. The primary objectives are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver an ablative, conformal dose distribution to liver lesions while maintaining established dose constraints to normal tissues, and to determine the maximum tolerated dose (MTD) of navigated percutaneous interstitial HDR brachytherapy for liver lesions.

enrolled patients will receive treatment using the same equipment, techniques and treatment planning as currently practiced at uTSW for liver lesion ablation and HDR afterloading brachytherapy, with the exception of the incorporation of an image-guided navigational workflow into the HDR catheter placement procedure and treatment at multiple escalating dose levels. Patients will undergo biopsies of lesions before and after administration of radiation dose.

Patients will be followed as per standard clinical practice, at a minimum of 2 months ((+-) 2 weeks) post-treatment and then approximately every 3 months ((+-) 2 weeks) for 1 year. They will be evaluated for toxicity referable to the treatment as well as clinical and radiographic evidence of lesion response. Thereafter, patients will be followed as clinically indicated.

a minimum of twenty-one patients (maximum of 45) will enroll into this protocol which is expected to take 48 months to complete. (36 months enrollment plus 12 months for terminal follow-up).

Dose Tiers:
1) 25 Gy Minimum Peripheral Dose
2) 30 Gy Minimum Peripheral Dose
3) 35 Gy Minimum Peripheral Dose

Participant Eligibility

3.1.1 Patients must have histologic or radiographic proof of a primary liver malignancy suitable for radiation therapy.
3.1.2 Lesion size >= 3cm in maximum dimension or >= 1cm and deemed a poor candidate for other ablative approaches
3.1.3 Predicted survival of >6 months.
3.1.4 KPS >= 60 (See Appendix B).
3.1.5 Age >= 18 years old.
3.1.6 Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
3.1.6.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

* Has not undergone a hysterectomy or bilateral oophorectomy; or

* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
3.1.7 Ability to understand and the willingness to sign a written informed consent.
3.1.8 Formal evaluation by the Liver Tumor Program at UTSW and/or review at the Liver Tumor Board: All patients should be fairly and prudently informed of their treatment options. To this end, all patients must be evaluated before brachytherapy treatment for discussion and consideration of other options for treatment of metastatic liver cancer including surgical resection.