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New treatment option for Esophageal Cancer
Official title 18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chemoradiation Treatment Response in Esophageal Cancer
ClinicalTrials.gov ID: NCT06414902
What this study is testing
What is ArabinoFuranosylGuanine [18F]F-AraG?
ArabinoFuranosylGuanine [18F]F-AraG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if 18F-FAraG PET scans can find tumors in participants with esophageal cancer and predict a participant's response to treatment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be ≥18 years of age
- Participants with locally advanced esophageal cancer
- Participants with untreated documented carcinoma of the esophagus that is \> 2 cm in patients who are going to receive systemic therapy concurrently...
- 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...
You likely can't join if
- Body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed
- Pregnant or lactating females - Pregnant women are excluded from this study because 18F-FAraG PET agent with the potential for teratogenic or...
- History of allergic reaction to intravenous contrast
- eGFR\<40 within 1 month prior to receiving 8F-FAraG
See the full eligibility criteria
- Participants must be ≥18 years of age
- Participants with locally advanced esophageal cancer
- Participants with untreated documented carcinoma of the esophagus that is \> 2 cm in patients who are going to receive systemic therapy concurrently with radiation as primary therapy are eligible
- 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
- The effects of 18F-FAraG PET on the developing human fetus are unknown. For this reason and because 18F-FAraG PET agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed
- Pregnant or lactating females - Pregnant women are excluded from this study because 18F-FAraG PET agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for...
- History of allergic reaction to intravenous contrast
- eGFR\<40 within 1 month prior to receiving 8F-FAraG
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.