Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 7/8/2018 |
| Start Date: | June 12, 2015 |
| End Date: | March 7, 2018 |
A Pilot Study of an Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization
Background:
- Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also
include other minimally invasive tumor treatments such as transarterial chemoembolization
(TACE). TACE treatment for liver cancer helps control the cancer but is not considered a
cure. Researchers want to learn more about the effects of TACE on liver tumors and
surrounding tissue. To do this, they will use a positive emission test (PET) and a
radioactive tracer called [18F] FMISO.
Objectives:
- To see if [18F] FMISO is useful for evaluating what happens to liver tumors and surrounding
tissue after TACE.
Eligibility:
- People age 18 and older with liver cancer who have been approved to have TACE.
Design:
- Participants will meet with a study researcher to see if they can take part in the
study.
- Participants will have TACE under a separate NCI protocol or at a hospital other than
the NIH Clinical Center.
- Before and after TACE, participants will have a CT and MRI of the abdomen. For these
scans, they will lie in a machine that takes pictures of their body. They will also have
blood tests and a physical exam.
- The [18F] FMISO imaging study will be performed at NIH only.
- Participants will have an intravenous catheter placed in their arm (if they do not have
one). The [18F] FMISO tracer will be injected.
- Participants will have PET-CT scans. Each scan will take about 30 minutes.
- Some participants will also have [18F] FMISO and PET-CT scans before TACE.
- As part of standard care for TACE, participants will have CT and MRI scans at regular
intervals. This will evaluate tumor response.
- Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also
include other minimally invasive tumor treatments such as transarterial chemoembolization
(TACE). TACE treatment for liver cancer helps control the cancer but is not considered a
cure. Researchers want to learn more about the effects of TACE on liver tumors and
surrounding tissue. To do this, they will use a positive emission test (PET) and a
radioactive tracer called [18F] FMISO.
Objectives:
- To see if [18F] FMISO is useful for evaluating what happens to liver tumors and surrounding
tissue after TACE.
Eligibility:
- People age 18 and older with liver cancer who have been approved to have TACE.
Design:
- Participants will meet with a study researcher to see if they can take part in the
study.
- Participants will have TACE under a separate NCI protocol or at a hospital other than
the NIH Clinical Center.
- Before and after TACE, participants will have a CT and MRI of the abdomen. For these
scans, they will lie in a machine that takes pictures of their body. They will also have
blood tests and a physical exam.
- The [18F] FMISO imaging study will be performed at NIH only.
- Participants will have an intravenous catheter placed in their arm (if they do not have
one). The [18F] FMISO tracer will be injected.
- Participants will have PET-CT scans. Each scan will take about 30 minutes.
- Some participants will also have [18F] FMISO and PET-CT scans before TACE.
- As part of standard care for TACE, participants will have CT and MRI scans at regular
intervals. This will evaluate tumor response.
Background
- TACE is the standard therapy for inoperable primary liver cancers or tumor control prior
to transplantation. The mechanisms for TACE s failure remains poorly understood.
- Although acute hypoxia and significant tumor necrosis occurs following TACE, the tumor
adaptive response and localization for such have not been well characterized.
- Imaging tools using a hypoxia-specific tracer [(18)F] FMISO may help identify the
pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated tumor
progression.
- The primary hypothesis of this study states that tumor progression post-TACE arises from
changes in tumor phenotype induced by treatment-related hypoxia superimposed on the
dynamic process of underlying tumor hypoxia.
Objectives
-To determine the feasibility of hypoxic tumor identification despite relatively high liver
background signal, and describe patterns of tumor hypoxia in the immediate post-TACE
treatment period using PET imaging [(18)F] MISO uptake registered with cross-sectional
imaging.
Eligibility
- Patients greater than or equal to 18 years with inoperable primary hepatic malignancy or
hepatic-dominant metastatic-disease and be otherwise eligible to receive TACE treatment.
Patients with hepatocellular carcinoma should have intermediate stage disease according
to the BCLC staging system (Stage A4 or B).
- Patients must not have had chemotherapy- or radiation therapy to liver for at least 2
weeks prior to starting study treatments.
- Patients must not have an acute, critical illness.
- Patients must not be pregnant
- Able to understand and be willing to sign a written informed consent
Design
- Fifteen patients with primary or metastatic liver malignancy will be enrolled into this
pilot, non-randomized, open study of the feasibility of using (18)F-fluoromisonidazole
PET scanning to determine hypoxic tumor identification and localization, and to identify
the pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated
tumor progression.
- Twenty-four to seventy-two hours after standard of care TACE, patients will undergo
PET scanning using 0.1mCi/kg (maximum 10mCi) of (18)F-fluoromisonidazole [(18)F] MISO).
- TACE is the standard therapy for inoperable primary liver cancers or tumor control prior
to transplantation. The mechanisms for TACE s failure remains poorly understood.
- Although acute hypoxia and significant tumor necrosis occurs following TACE, the tumor
adaptive response and localization for such have not been well characterized.
- Imaging tools using a hypoxia-specific tracer [(18)F] FMISO may help identify the
pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated tumor
progression.
- The primary hypothesis of this study states that tumor progression post-TACE arises from
changes in tumor phenotype induced by treatment-related hypoxia superimposed on the
dynamic process of underlying tumor hypoxia.
Objectives
-To determine the feasibility of hypoxic tumor identification despite relatively high liver
background signal, and describe patterns of tumor hypoxia in the immediate post-TACE
treatment period using PET imaging [(18)F] MISO uptake registered with cross-sectional
imaging.
Eligibility
- Patients greater than or equal to 18 years with inoperable primary hepatic malignancy or
hepatic-dominant metastatic-disease and be otherwise eligible to receive TACE treatment.
Patients with hepatocellular carcinoma should have intermediate stage disease according
to the BCLC staging system (Stage A4 or B).
- Patients must not have had chemotherapy- or radiation therapy to liver for at least 2
weeks prior to starting study treatments.
- Patients must not have an acute, critical illness.
- Patients must not be pregnant
- Able to understand and be willing to sign a written informed consent
Design
- Fifteen patients with primary or metastatic liver malignancy will be enrolled into this
pilot, non-randomized, open study of the feasibility of using (18)F-fluoromisonidazole
PET scanning to determine hypoxic tumor identification and localization, and to identify
the pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated
tumor progression.
- Twenty-four to seventy-two hours after standard of care TACE, patients will undergo
PET scanning using 0.1mCi/kg (maximum 10mCi) of (18)F-fluoromisonidazole [(18)F] MISO).
- INCLUSION CRITERIA:
- Patients must have confirmed inoperable primary hepatic malignancy or hepatic dominant
metastatic - neoplastic disease evidenced by histology or cytology, or characteristic
enhancement pattern on CT or MRI together with an abnormal serum alpha-fetoprotein
>200mg/dl in the case of hepatocellular carcinoma.
- Patients with hepatocellular carcinoma should conform to intermediate stage disease
according to the BCLC(16) staging system (Stage A4 or B) and be otherwise eligible to
receive TACE treatment.
- Patients must have had no chemotherapy or radiotherapy to the liver therapy for, their
malignancy for at least 2 weeks (or until response can be adequately assessed) prior
to treatment and must have recovered from all clinically significant side effects of
therapeutic and diagnostic interventions.
- Serum creatinine less than or equal to 2.0 mg/dl unless the measured creatinine
clearance is greater than 60ml/min
- Age greater than or equal to18 years
- Ability of subject to understand and willingness to sign a written informed consent
document
- Patient must be able to lie still for the procedure
- ECOG status less than or equal to 2
- In addition, for patients receiving TACE outside NIH:
- Patient must have physician willing to collaborate with NIH PI by providing
required medical record and digital MR/ CT scan documentation pre and post TACE
procedure.
- Patient must be willing to sign an Authorization for the Release of Medical
Information form
EXCLUSION CRITERIA:
- Patients who have received prior TACE treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to misonidazole or other agents used in study.
- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
- Patients of childbearing age must not be pregnant. The effects of [(18)F]FMISO on the
developing human fetus are unknown. Pregnancy is a contraindication for TACE.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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