Imaging Biomarker for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Steven H. Lin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Lactation, Allergic reaction, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

To learn if 18F-FAraG PET scans can find tumors in participants with esophageal cancer and predict a participant's response to treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does this imaging treatment for esophageal cancer differ from other treatments?

This treatment uses a special imaging technique called FLT-PET, which helps detect early changes in tumor growth after chemoradiotherapy, allowing for more personalized treatment plans. Unlike standard treatments that focus on directly attacking the cancer, this approach focuses on monitoring the cancer's response to therapy.

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Eligibility Criteria

This trial is for adults over 18 with untreated esophageal cancer larger than 2 cm, who will receive chemo and radiation. They must be able to consent, not pregnant or breastfeeding, agree to use birth control, and have a body weight under 400 pounds without conditions preventing imaging.

Inclusion Criteria

Ability to provide written informed consent in accordance with institutional policies

Female participants of childbearing potential must have a negative serum or urine pregnancy test within 1 week of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical

I have an untreated esophagus cancer larger than 2 cm and will get systemic therapy with radiation.

Exclusion Criteria

Pregnant or lactating females

History of allergic reaction to intravenous contrast

I weigh over 400 pounds or have a condition that prevents me from undergoing certain scans.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Imaging

Participants undergo standard-of-care imaging and 18F-FAraG PET scan before starting treatment

1 week

1 visit (in-person)

Chemoradiation Treatment

Participants receive chemoradiation treatment for esophageal cancer

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial is testing if a PET scan using the tracer ArabinoFuranosylGuanine (18F-F-AraG) can detect esophageal tumors and predict how well patients respond to chemoradiation treatment.

Group I: 18F-FAraG PET Experimental Treatment 1 Intervention

Participants found to be eligible to take part in this study, participant will have a 18F-FAraG PET scan as described below. Before you start treatment, you will have standard-of-care imaging and then undergo the research 18F-FAraG PET scan. About 20 minutes before the injection of the 18F-FAraG imaging tracer, you will drink two 8-ounce bottles of water to help clear the imaging tracer from your kidneys.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of response to neoadjuvant therapy by quantitative 2-deoxy-2-[18F]fluoro-D-glucose with positron emission tomography in patients with esophageal cancer. [2019] This work evaluates positron emission tomography (PET) with 2-deoxy-2-[18F]fluoro-D-glucose (FDG) in assessing response to therapy in patients with esophageal cancer.

2. England pubmed.ncbi.nlm.nih.gov

PET/CT in the evaluation of treatment response to neoadjuvant chemoradiotherapy and prognostication in patients with locally advanced esophageal squamous cell carcinoma. [2019] To investigate the role of fluorine-18-fluorodeoxyglucose PET/computed tomography for the prognostication and evaluation of neoadjuvant chemoradiotherapy response in locally advanced esophageal squamous cell carcinoma.

3. England pubmed.ncbi.nlm.nih.gov

[18 F]Fluorodeoxyglucose PET/CT and prediction of histopathological response to neoadjuvant chemotherapy for adenocarcinoma of the oesophagus and oesophagogastric junction. [2018] Label="BACKGROUND">The aim of this prospective study was to assess whether [18 F]fluorodeoxyglucose PET can be used to predict histopathological response early in the course of neoadjuvant chemotherapy in patients with adenocarcinoma of the oesophagus and oesophagogastric junction.

4. United States pubmed.ncbi.nlm.nih.gov

Early detection of chemoradioresponse in esophageal carcinoma by 3'-deoxy-3'-3H-fluorothymidine using preclinical tumor models. [2016] Early identification of esophageal cancer patients who are responding or resistant to combined chemoradiotherapy may lead to individualized therapeutic approaches and improved clinical outcomes. We assessed the ability of 3'-deoxy-3'-(18)F-fluorothymidine positron emission tomography (FLT-PET) to detect early changes in tumor proliferation after chemoradiotherapy in experimental models of esophageal carcinoma.

5. England pubmed.ncbi.nlm.nih.gov

Molecular biological correlation of fluorine-18 fluorodeoxyglucose uptake in esophageal squamous cell carcinoma. [2019] The aim of this study was to assess the relationship between fluorine-18 fluorodeoxyglucose (F-FDG) uptake and molecular biological markers in esophageal squamous cell carcinoma (ESCC) patients.