NCT05250895CompletedEarly phase 1
BOLD MRI and FMISO PET for the Assessment of Hypoxic Tumor Microenvironment in Patients with Oligometastatic Liver Cancer Undergoing Yttirum-90 Selective Internal Radiation Therapy
Molecular Imaging of the Hypoxic Tumor Microenvironment to Predict Response to Yttirum-90 Selective Internal Radiation Therapy in Hepatocellular Carcinoma- Pilot Study
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
This early phase I trial evaluates the use of hypoxia (lack of oxygen) as a measure in determining the outcome of Y90 selective internal radiation therapy in patients with liver cancer that has spread to a limited number of sites (oligometastatic). Radioembolization with Y90 is a minimally invasive procedure that combines embolization and radiation therapy to treat metastatic liver cancer. Tiny beads filled with radioactive isotope Y-90 are placed inside the blood vessel that provide blood supply to the tumor. This will block the blood flow to the tumor cells while providing a high radiation dose without harming healthy normal tissue.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 22 Dec 2021
- Start date
- 28 Apr 2022
- Primary completion date
- 26 Feb 2025
- Lead sponsor
- Emory University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05250895
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 9
- From 28 Apr 2022 to the primary completion date, 26 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are definite transplant candidates
- Concurrent second malignancy outside of the liver
- Previous liver-directed therapy to targeted tumors
Lab values
- Bilirubin \> 2 mg/dL for lobar treatment and bilirubin \> 3 mg/dL for segmental or bi-segmental Y90-SIRT
- Albumin \< 3 g/dL
Other
- Infiltrative liver tumor
- BCLC stage D
- Projected lung dose of \> 30 Gy in a single session to the liver after prospective treatment planning
- Body mass index (BMI) \> 40
Who the study is looking for
- Age \>= 18 years
- Established HCC diagnosis, unilobar or bilobar disease
- At least 1 tumor \>= 3 cm
- Oligometastatic disease
- Barcelona Clinic Liver Cancer (BCLC) stage A, B or C
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy \> 12 weeks as determined by the Investigator
- The effects of Y90 Radioembolization on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.