Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers

NCT03403465 | Active Not Recruiting Phase 2

• 1 other identifier: Pro00089619
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study expands on protocol (NCT01908504"PET adaptive RT") designed to evaluate the utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in many malignant diseases as a curative treatment modality. However, critical normal tissue is often in close approximation to disease, and portions of such tissue must receive high doses of radiation for appropriate treatment. Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current protocol, may allow for a means of determining the eventual response to therapy, at a time point when adaptation of treatment plan may be possible to improve outcomes. This protocol will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The current focus will be more specific to certain types of gastrointestinal and gynecologic cancers treated with RT, identified from the prior study to warrant further research.

Conditions

Cancer of the Cervix; Vulvar Cancer; Esophageal Cancer; Anal Canal Cancer

Outcome Measures

Primary Outcomes (6)

• The number of subjects with benefit from an intra-treatment PET-CT

  This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly

  4 years

• Pathologic complete response

  Pathologic complete response will be collected from pathology reports for subjects who have surgical resection after radiation therapy.

  4 years

• Locoregional control

  This study will evaluate the prognostic value of intra-treatment functional imaging on clinical relevant tumor endpoints (i.e. locoregional control, freedom from distant metastases, and overall survival).Comparison of intra-treatment FDG-PET indices will identify two groups of responses: PET responses and PET non-responses, which will correlate with prognosis.

  Day of intra treatment PET-CT/ approx 2-4 hours

• Freedom from distant metastases

  Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care, or at the treating investigator's discretion. Frequency of follow up will be determined by the standard practice for the disease site and stage.

  4 years

• Measure overall survival (OS)

  Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site

  4 years

• Progression free survival (PFS)

  Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care for each disease site

  4 years

Secondary Outcomes (1)

• Measure the potential sparing of radiation dose to critical normal tissue

  4 years

Study Arms (1)

Single arm interventional study

OTHER

Research FDG-PET scan obtained before radiation therapy; a second research FDG-PET scan is obtained at about 3-5 weeks after treatment has started.

Other: FDG PET scan

Interventions

FDG PET scan OTHER

At radiation planning subjects will have a PET-CT. The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.

Also known as: PET scan

Single arm interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically (histologically or cytologically) proven diagnosis of cervical, vulvar, esophageal and anal canal cancer
• Patients with local or regional nodal disease are eligible
• Zubrod Performance Status 0, 1, or 2
• Age ≥ 18
• Negative serum pregnancy test for women of child bearing potential
• Patient must sign study-specific informed consent prior to study entry

You may not qualify if:

• No gross disease visible on imaging at the start of radiotherapy
• Contraindication to PET
• Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
• Breast feeding
• Positive serum pregnancy test

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vulvar Neoplasms; Esophageal Neoplasms; Anal Canal Carcinoma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvar Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Junzo Chino, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: March 27, 2018
• Primary Completion (Estimated): April 5, 2028
• Study Completion (Estimated): April 5, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)