Hepatocellular Carcinoma
Conditions
Brief summary
It is thought that PET of the abdomen with 11C Acetate will provide new information regarding whether or not patient's have benefited from radiotherapy. To test this theory, the project will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of treatment success.
Interventions
DRUG11C-Acetate
The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq). There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient
Sponsors
Justin Sims
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years of age * Subject is willing to participate in the study and has signed the study informed consent * Subject is available and willing to comply with the protocol evaluations * Diagnosed hepatocellular carcinoma confined to a single lobe of the liver if undergoing 90Y radioembolization * Diagnosed hepatocellular carcinoma confined to the liver if undergoing Stereotactic Body Radiation Therapy (SBRT) * Under consideration for 90Y radioembolization or Stereotactic Body Radiation Therapy (SBRT)
Exclusion criteria
* Pregnant or planning to become pregnant within the next 12 months or breast-feeding * GFR \< 45 * Life expectancy \< 6 months * Claustrophobic and cannot tolerate imaging procedures * Weigh \> 350 lb (upper weight limit of scanner beds) * Special vulnerabilities (e.g. fetuses, neonatales, pregnant women, children, prisoners, institutionalized individuals).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate | At three months | The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiotherapy Treatment Monitoring of Hepatocellular Carcinoma All patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points.
11C-Acetate: The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).
There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Radiotherapy Treatment Monitoring of Hepatocellular Carcinoma | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | — |
| Number of participants | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 1 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate
The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.
Time frame: At three months