F18-DCFPyL for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Washington DC VA medical Center, Washington, United States
Carcinoma+2 More
F18-DCFPyL - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a new tracer can help identify sites of HCC better than current standard imaging.

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Eligible Conditions

  • Carcinoma
  • Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether F18-DCFPyL will improve 1 primary outcome and 2 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of Baseline, post ablation, disease progression.

Baseline, post ablation, disease progression
Lesion level sensitivity, specificity and positive predictive value
Positive predictive value
Pre- and post-treatment HCC treatment
Change in 18F-DCFPyL PET/CT uptake between pre- and post-treatment

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

1/Baseline and Post-treatment Imaging
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. F18-DCFPyL is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

1/Baseline and Post-treatment Imaging18F-DCFPyL PET/CT imaging, CT and/or MRI and standard of care local ablative treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2310
CT
2017
Completed Phase 3
~2750

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post ablation, disease progression
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, post ablation, disease progression for reporting.

Closest Location

Washington DC VA medical Center - Washington, United States

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text states that the patient is eligible for local therapies, which include surgical resection, stereotactic radiation therapy, transarterial chem/radio/bland embolization, microwave ablation, and radiofrequency ablation. show original
The ability to take oral medication and the willingness to adhere to the study intervention regimen are both necessary for participation in the study. show original
Individuals known to be infected with human immunodeficiency virus (HIV) must be on effective anti-retroviral therapy with an undetectable viral load within 6 months. show original
The person has a high suspicion of having hepatocellular carcinoma, and they have at least one measurable lesion on a standard imaging modality. show original
The effects of 18F-DCFPyL (study drug) on the developing human fetus are unknown. For this reason and because this agent as well as other therapeutic agents used in this trial are known to be teratogenic, 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 and for 2 months after each study PET/CT imaging. 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.
The ability of the subject to understand and the willingness to sign a written informed consent document are both important factors in determining whether or not a subject can participate in a clinical trial. show original
The ECOG performance status is equal to or less than 2. show original
Age >=18 years.
People with chronic hepatitis B virus infection must take medication to suppress the virus so that it is undetectable. show original
If you have a history of hepatitis C virus infection, you must have been treated and cured. show original

Patient Q&A Section

What does f18-dcfpyl usually treat?

"The strong correlations between tumor size and F18-dcfpyl uptake suggest that F18-dcfpyl might be a useful tool for assessing tumor response at early time points. However, further studies are needed to determine whether F18-dcfpyl PET might have limited role in predicting tumor response in patients receiving chemotherapy after surgery." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of f18-dcfpyl?

"The common side effects of f18-dcfpyl were generally mild. The most common side effect was headache. Other common side effects included fatigue, dizziness, nausea, vomiting, and diarrhea. Patients should report all side effects so they can be evaluated and treated appropriately." - Anonymous Online Contributor

Unverified Answer

Has f18-dcfpyl proven to be more effective than a placebo?

"Data from a recent study shows that the F18-dcpyl PET scan was significantly superior to the patient's history and physical examination for predicting survival after resection for HCCA. The authors concluded that this imaging modality may be useful in identifying candidates for liver transplantation who might benefit from an aggressive surgical approach." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma, hepatocellular?

"The average age at diagnosis of hepatocellular carcinoma was 61.5 years (average +/-SD=13.8, range = 27-87 years). This is consistent with the general population incidence of HCC and roughly time period of expected occurrence for HCC in the United States. Findings from a recent study suggest that risk factors for HCC differ by tumor site." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, hepatocellular?

"Findings from a recent study have implications for routine follow-up care of patients with HCC as well as clinical trial design. A high preoperative serum AFP level is an independent prognostic parameter for HCC. Findings from a recent study suggest that this parameter should be incorporated into future staging criteria." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in f18-dcfpyl for therapeutic use?

"The FDA has approved [(18)F]FDG for PET imaging of tumors. DcfpyL is a novel molecule for use in PET imaging of non-neoplastic disease states and in particular for use in imaging tumors. This compound reflects expression of the MUC4 mucin gene product and thereby may serve as a surrogate marker for MUC4 overexpression. In addition, the drug's labeling properties make it advantageous in double-labeling studies where tumor markers and their analogs are used to image tumors and their metastases. (ClinicalTrials.gov Identifier: NCT00419018." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, hepatocellular spread?

"Hepatic metastases are very rare and can be clinically and radiographically detected within 6 months after liver transplantation. Yet, some patients with an initial negative CT scan remain free of tumor progression for up to 10 years. The risk factors for early liver recurrence must now be clearly defined." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, hepatocellular?

"The most common cause of hepatocarcinoma is chronic liver disease secondary to viral hepatitis B or chronic alcoholic cirrhosis. In addition to this, chronic cholestasis and certain congenital disorders such as hereditary hemochromatosis may also increase the risk of hepatocarcinoma." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing carcinoma, hepatocellular?

"The incidence of HCC in these groups was 1 per 100,000 persons and 0.6 per 100,000 persons, respectively. For both groups, the underlying cirrhosis had a much higher risk than for the general population." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, hepatocellular?

"Carcinoma, hepatocellular (HCC) is a disease of the liver and is thought to be caused by accumulation of mutated hepatocytes. The risk factors for HCC are obesity, alcohol intake, hepatitis B and C infection, non-alcoholic fatty liver disease, iron overload, diabetes mellitus, and chronic inflammation." - Anonymous Online Contributor

Unverified Answer

Is f18-dcfpyl typically used in combination with any other treatments?

"Findings from a recent study of this study support the theory that F18-dcfpyl can be used alone to treat patients with advanced hepatocellular carcinoma. However, when administered in combination with other drugs, F18-dcfpyl increases the efficacy and reduces toxicity. Thus, we would recommend combining F18-dcfpyl with other drugs to treat patients with advanced hepatocellular carcinomas." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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