CLINICAL TRIAL

F-18 Fluoroethyltyrosine (FET) for Cancer

1 Prior Treatment
Metastatic
Recurrent
Recruiting · Any Age · All Sexes · San Francisco, CA

This study is evaluating whether a new imaging agent may help doctors see tumors better during a PET scan.

See full description

About the trial for Cancer

Eligible Conditions
Glioma · Recurrent WHO Grade III Glioma · Glioblastoma · Brain Neoplasms · Neoplasms · Low Grade Glioma (LGG) · Neoplasms, Intracranial · Recurrent Glioblastoma · Recurrent World Health Organization (WHO) Grade II Glioma

Treatment Groups

This trial involves 2 different treatments. F-18 Fluoroethyltyrosine (FET) 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
F-18 Fluoroethyltyrosine (FET)
DRUG
Positron Emission Tomography (PET)
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography (PET)
2019
Completed Phase 3
~1220

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Cancer or one of the other 8 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age > 3 years.
The study looked at the presence or suspicion of intracranial neoplasms in two populations: patients with primary headaches and patients with secondary headaches. show original
Metastatic lesions that come back. show original
Tumors that continue to grow and spread quickly are called recurrent high-grade gliomas. show original
Low-grade gliomas that come back ( grades 1 and 2). show original
Patients who have not yet had a biopsy or surgery to remove their cancer. show original
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether F-18 Fluoroethyltyrosine (FET) will improve 2 primary outcomes and 2 secondary outcomes in patients with Cancer. Measurement will happen over the course of Day 1.

Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2)
DAY 1
Readers will have access only to FET PET images for Patients with suspected glial neoplasms (Grade 2-4) planning to undergo biopsy or surgery prior to primary treatment during evaluation and will grade the lesions in a binary fashion as having Grade II glial neoplasms or having Grade III/IV glial neoplasms. True positive (TP2): FET PET read as positive for Grade III/IV neoplasm, pathology demonstrates Grade III/IV neoplasm. False positive (FP2): FET PET read as positive for Grade III/IV neoplasm, pathology demonstrates Grade II neoplasm. True negative (TN2): FET PET read as positive for Grade II neoplasm, pathology demonstrates Grade II neoplasm. False negative (FN2): FET PET read as positive for Grade II neoplasm, pathology demonstrates Grade III/IV neoplasm. Misclassification rate = [FP2+FN2]/[FP2+FN2+TP2+TN2]
DAY 1
Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 1)
DAY 1
Radiologists will classify lesions based on imaging as either having recurrent disease or not having recurrent disease. True Positives (TP) are defined as an FET PET read positive for tumor and pathology/follow-up demonstrates tumor recurrence in at least one biopsy sample, False positives (FP) are defined as an FET PET read positive for tumor and pathology/follow-up demonstrates negative tumor recurrence in all of the biopsy samples, True negatives (TN) are defined as an FET PET read as negative for tumor and pathology/follow-up also negative tumor recurrence in all of the biopsy samples and a false negative (FN) is defined as an FET PET read as negative for tumor and pathology/follow-up demonstrates tumor recurrence in at least one biopsy sample. Misclassification rate = [FP+FN)]/[FP+FN+TP+TN]
DAY 1
Binary characterization of follow-up imaging as positive/negative for tumor recurrence
UP TO 6 MONTHS
In the absence of pathology, imaging will be used for correlation. Positive for tumor recurrence on follow-up imaging as correlate endpoint will be defined as a greater than 50% increase in the enhancing component of the lesion. If there is less than 50% increase in the enhancing component of the lesion, then it will be considered negative for tumor recurrence on follow-up. Follow-up imaging has to be performed within six months of the FET PET imaging study.
UP TO 6 MONTHS
Misclassification rate for FET PET in the evaluation of recurrent low-grade gliomas (Population 1)
UP TO 6 MONTHS
Low-grade glioma is defined by low uptake of FET. Radiologists will classify lesions based on imaging as either having recurrent disease or not having recurrent disease. True Positives (TP1L) are defined as an FET PET read positive for low-grade tumor and pathology/follow-up demonstrates low-grade tumor recurrence in at least one biopsy sample, False positives (FP1L) are defined as an FET PET read positive for low grade tumor recurrence and pathology/follow-up demonstrates negative low-grade tumor recurrence in all of the biopsy samples, True negatives (TN1L) are defined as an FET PET read as negative for low-grade tumor recurrence and pathology/follow-up also negative for low grade tumor recurrence in all of the biopsy samples and a false negative (FN1L) is defined as an FET PET read as negative for low grade tumor recurrence and pathology/follow-up demonstrates low grade tumor recurrence in at least one biopsy sample. Misclassification rate = [FP1L+FN1L)]/[FP1L+FN1L+TP1L+TN1L]
UP TO 6 MONTHS

Patient Q & A Section

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

What are the signs of cancer?

The signs and symptoms of cancer are quite variable, depending on the type of cancer. Common signs in breast, cervix and colon cancer include lump in the breast, persistent vaginal bleeding or abdominal pain for colorectal cancer, and persistent, recurrent or unexplained vaginal bleeding or bleeding after sexual intercourse for cancers of the cervix, anus and uterus. Common signs of lymphoma include a painless soft lump in breast. Signs of lung cancer include a cough or worsening shortness of breath. Common signs of melanoma include a mole or bump on the skin, black, itchy bumps that don't heal completely, bleeding from nail, or an ulcer inside the nail.

Anonymous Patient Answer

Can cancer be cured?

There is not a single and simple procedure by which a diagnosed cancer can be cured. Rather, a multi-stage therapeutic approach should be taken, as dictated by the situation at the time of diagnosis.

Anonymous Patient Answer

How many people get cancer a year in the United States?

More than 25 million annual new cancer cases will be diagnosed in the United States in 2020. About 35% of all new cases will be breast cancer, 14% will be non-Hodgkin lymphoma, 12% will be colorectal cancer, and 9% will be prostate cancer. On average, men are at risk for being diagnosed with cancer at a younger age, and women at a later age, compared to the general population. The incidence, prevalence and mortality of various forms of cancer differ from year to year. More than 5.7 million people in the United States could be diagnosed with cancer in 2019.

Anonymous Patient Answer

What causes cancer?

In order to understand the complex pathogenesis of cancer, it will become increasingly important to understand how the body normally defends itself in the face of harmful stimuli such as tobacco smoke, asbestos fibers, and X-rays.

Anonymous Patient Answer

What are common treatments for cancer?

Most cancer patients receive a prescription medication; but sometimes these patients receive complementary treatment(s), which are often not prescribed on a regular basis, for example: homeopathy, herbal medicines, acupuncture, acupuncture-moxibustion, or dietary supplements as part of the cancer treatment.

Anonymous Patient Answer

What is cancer?

It is time we acknowledge the human price that cancer has caused in our communities. It is time we unite in our effort to raise awareness of the disease and in our call for funding of research through the U.S. Community Cancer Network and American Cancer Society. Let us fight together to see that these funds continue to support the best and most effective cancer treatments and that each family is given the best care possible.

Anonymous Patient Answer

What is the primary cause of cancer?

The primary cause of cancer is not simple. It is multiple and it is also a complex relationship between the patient, the tumor cells and the environment. The interaction of the factors result in different types of cancer at different sites. Cancer prevention and cancer treatment should targets only those important variables and factors that contribute to tumorigenesis and subsequent progression.

Anonymous Patient Answer

What does f-18 fluoroethyltyrosine (fet) usually treat?

Results from a recent paper demonstrates the value of determining drug levels. The FET PET scan has shown that tumor uptake of FET is a good indicator of tumor burden in a majority of subjects. The scan helps to predict which patients' tumors respond to therapy and when patients experience clinically significant response.

Anonymous Patient Answer

Have there been other clinical trials involving f-18 fluoroethyltyrosine (fet)?

The present study indicates that PET or other imaging modalities cannot replace TST for the detection of [thyroid cancer](https://www.withpower.com/clinical-trials/thyroid-cancer) during evaluation of patients with elevated serum TSH, particularly in patients with differentiated thyroid carcinoma.

Anonymous Patient Answer

What is f-18 fluoroethyltyrosine (fet)?

Fet is an amine used to image the central nervous system(CNS). It has also been reported to cause neurotoxicity in high plasma levels and hence is not used clinically at the doses that have been used in this study. The LD of fet is approximately 1.5 mg/kg. Fet also has low (6% bioavailability) protein binding. Fet will be readily metabolized and eliminated via the biliary system, particularly the cytochrome P450 enzymes.

Anonymous Patient Answer

How serious can cancer be?

I have known many people that died of cancer and none of them seemed to die quick enough for me to complain. In spite of all the efforts people make to save their lives, they still die. I have learned that even though there are some benefits to a good quality of life, there are also some limitations to what people are able to give up to their survival. I have realized that we cannot cure everyone from cancer. And I believe that to be successful in our struggle to save our lives from cancer, it comes down to the people’s will to live. I do believe that to achieve high quality of lifes we have to commit to living, no matter how difficult it is.

Anonymous Patient Answer

How quickly does cancer spread?

After radical surgery cancer does not spread quickly - cancer cells are still found in most organs 2 years later. Yet for many years cancer has been known so doctors have wondered whether cancer spreads or whether it is just metastasising. We now know that cancer spreads very slowly - and this is one of the first pieces of data to explain that cancer is not just 'a disease of fast growth and spread'.

Anonymous Patient Answer
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