CLINICAL TRIAL

3'-deoxy-3'-[18F]fluorothymidine for Syndrome

Recruiting · 18+ · All Sexes · Detroit, MI

This study is evaluating whether FLT PET imaging can help find and diagnose cancer.

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About the trial for Syndrome

Eligible Conditions
Syndrome · Multiple Myeloma and Plasma Cell Neoplasm · Central Nervous System Neoplasms · Myelodysplastic/Myeloproliferative Neoplasms · Unspecified Adult Solid Tumor, Protocol Specific · Brain and Central Nervous System Tumors · Myeloproliferative Disorders · Chronic Myeloproliferative Disorders · Myelodysplastic-Myeloproliferative Diseases · Disorders, Lymphoproliferative · Lymphoproliferative Disorders · Preleukemia · Nervous System Neoplasms · Multiple Myeloma · Myelodysplastic Syndromes · Leukemia · Neoplasms · Plasmacytoma · Neoplasms, Plasma Cell · Lymphoma · Disease

Treatment Groups

This trial involves 2 different treatments. 3'-deoxy-3'-[18F]fluorothymidine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
3'-deoxy-3'-[18F]fluorothymidine
DEVICE
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
3'-deoxy-3'-[18F]fluorothymidine
2012
Completed Phase 1
~130

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically confirmed solid tumor or hematologic malignancy
Awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging
Able to lie still in the PET scanner
Girth and weight must be suitable to enter the gantry
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Not specifie
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: before and after therapy
Screening: ~3 weeks
Treatment: Varies
Reporting: before and after therapy
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: before and after therapy.
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 3'-deoxy-3'-[18F]fluorothymidine will improve 2 primary outcomes and 1 secondary outcome in patients with Syndrome. Measurement will happen over the course of before and after therapy.

Changes in thymidine kinase, thymidylate synthase, and standardized uptake values
BEFORE AND AFTER THERAPY
BEFORE AND AFTER THERAPY
FLT PET response rate
UP TO 2 HOURS DURING PET SCAN
UP TO 2 HOURS DURING PET SCAN
Measurement of the uptake and retention of 3'-deoxy-3'-[18F] fluorothymidine (FLT) in tumors and normal organs
AT TIME OF PET OR CT PET SCAN
AT TIME OF PET OR CT PET SCAN

Who is running the study

Principal Investigator
A. F. S.
Anthony F. Shields, MD PhD
Barbara Ann Karmanos Cancer Institute

Patient Q & A Section

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

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

Syndromes are a very common illness in the US, and many cases are diagnosed in primary care. There are significant racial and socioeconomic differences with no evidence of differences in diagnostic rate for the various syndromes.

Anonymous Patient Answer

What is syndrome?

Syndromes are groups of signs or symptoms that are commonly associated with each other, such that they form clinical syndromes. In the absence of a clinical diagnosis to explain the presence of multiple symptoms, syndromes are considered and used as a diagnostic tool.

Anonymous Patient Answer

What are the signs of syndrome?

Signs of syndrome usually have a rapid onset and are present for up to 6 months. These signs are suggestive of thyroid disease, systemic lupus erythematosus, or other autoimmune diseases such as rheumatoid arthritis, Sjögren syndrome, or dermatomyositis. The exact location of the lesions is also helpful in diagnosing a particular syndrome.

Anonymous Patient Answer

Can syndrome be cured?

While there is some evidence for the possibility of cure, it is not clear that it is an ethical goal. Symptom management may make remission possible.

Anonymous Patient Answer

What causes syndrome?

There is no definite cause for a condition. Symptoms that occur in a pattern that may indicate a specific disorder, but do not meet the other requirements for a syndrome, have been defined as syndromes. There are no specific symptoms which exclude a diagnosis, and some conditions may be syndromes rather than diseases. Syndromes are often poorly recognized and misunderstood, and the diagnosis of a syndrome does not give a cure, the only aim of treatment.

Anonymous Patient Answer

What are common treatments for syndrome?

Syndromes have many treatments, including a combination of behavioral therapy, medication for anxiety, and supportive social and leisure activities. Some people with syndromes may utilize the services of a professional to address specific treatment goals.

Anonymous Patient Answer

Who should consider clinical trials for syndrome?

All these factors, as well as the patients' decision-making power, should be considered by a clinician in order to make the best clinical trial decision. Future research could explore more aspects of clinical trials.

Anonymous Patient Answer

What are the common side effects of 3'-deoxy-3'-[18f]fluorothymidine?

[18F]FLT is well tolerated by patients. No side effects were observed in more than 5% of subjects. Common [18F]FLT side effects were dyspnoea, fatigue, and headache; no side effects were observed in more than 2% of subjects. These [18F]FLT side effects were generally mild to moderate. Other side effects of 3'- deoxy-3'-[18F]- thymidine are generally consistent with [18F]FLT side effects, although they occurred at higher rates with [18F]FLT.

Anonymous Patient Answer

What is the average age someone gets syndrome?

The majority of patients with suspected syndrome at the time of referral by their GP are over 45. The age-based thresholds for referrals have been set out but need to be revised as the data suggests that these thresholds can be revised over time.

Anonymous Patient Answer

How serious can syndrome be?

The main symptoms are usually mild and only rarely serious. However, people with symptomatic AS can still suffer from severe mental and physical problems and have a poor prognosis. AS can increase the risk of heart failure by up to 14 times. It can increase a person's cardiovascular risks by 40 times. Overall, the risk of cardiac events is 3-7 times higher, that is, the risk of dying from any cause 4-6 times higher and the risk of dying from a heart attack almost 9 times higher than a person without AS. The more symptoms AS has, the greater the risks.

Anonymous Patient Answer

What is the latest research for syndrome?

All of the disorders listed in this article have been characterized in scientific literature in reputable major medical journals, except hereditary gingival fibromatosis and hereditary coproporphyria syndrome. If a clinical diagnosis is challenging, researchers at the NIH can help by identifying and assessing syndromes that have been characterized by the scientific community. You can also use the ClinicalTrials.gov site by following the links for the condition of interest on the NIH homepage, for example the links for Syndromic Lipomatosis, Lipomatosis in Infancy and the Syndromes of Fibrogenesis website for syndromic lipomatosis. ClinicalTrials.

Anonymous Patient Answer
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