New PET tracer could reveal hidden cancer response
NCT ID NCT06414902
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether a special PET scan using a radioactive tracer called 18F-AraG can find tumors in people with esophageal cancer and predict how well they respond to chemoradiation. About 60 adults with untreated, locally advanced esophageal cancer will receive the tracer and be scanned. The main goal is to check safety, but researchers also hope to see if the scan can serve as a biomarker for treatment response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-AraG (a radioactive tracer given by IV)
- What this could lead to
- If successful, this could give doctors a new way to see if chemoradiation is working in esophageal cancer patients, potentially guiding better treatment decisions.
- What could go wrong
- This is a very early Phase 1 study with only 60 people. The main goal is safety, not yet proving the scan predicts response. It may not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants must be ≥18 years of age 2. Participants with locally advanced esophageal cancer 3. 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 4. Ability to provide written informed consent in accordance with institutional policies 5. 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 6. 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 child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following: * 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. 7. 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, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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. Exclusion Criteria: 1. Body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed 2. 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 adverse events in nursing infants secondary to treatment of the mother with \[Agent\], breastfeeding should be discontinued if the mother is treated with \[Agent\]. These potential risks may also apply to other agents used in this study. 3. History of allergic reaction to intravenous contrast 4. eGFR\<40 within 1 month prior to receiving 8F-FAraG
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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