18F-FSPG PET/CT as a Non-Invasive Imaging Biomarker for Treatment Response to Chemoradiation in Esophageal Cancer

NCT ID: NCT06549413

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-23

Study Completion Date

2027-12-31

Brief Summary

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This study is being done to learn how 18F-FSPG PET/CT scan results may be related to the response to chemotherapy and radiation in patients with esophageal cancer.

Detailed Description

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PRIMARY OBJECTIVES:

I. Evaluate the ability of 18F-FSPG PET imaging to detect tumors in patients with esophageal cancer.

Conditions

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Esophageal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Patients receive 18F-FSPG IV and undergo a PET/CT scan. During week 3 of standard of care radiation therapy, patients receive 18F-FSPG and undergo a second PET/CT scan on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \* ≥ 18 years of age

* Patients with locally advanced esophageal cancer
* Patients with untreated documented carcinoma of the esophagus that is \> 2 cm who are going to receive systemic therapy concurrently with radiation as primary therapy
* Ability to provide written informed consent in accordance with institutional policies
* Female subjects 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

Exclusion Criteria

* \* Body weight ≥ 400 pounds or body habitus or disability that will not permit the imaging protocol to be performed

* Pregnant or lactating females
* Have an allergy to intravenous contrast
* eGFR \< 30
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven H Lin, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Steven H Lin, MD, PHD

Role: CONTACT

713-563-2300

Facility Contacts

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Steven H. Lin, MD, PHD

Role: primary

713-563-2300

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2023-04988

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-0989

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0989

Identifier Type: -

Identifier Source: org_study_id

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