Using PET imaging to define esophageal cancer boundaries
Predicting Esophageal Cancer Borders Using PET-Imaging PEGASUS
PHASE2 · University Hospital Heidelberg · NCT06408116
This study is testing if using advanced imaging techniques can help doctors better see the edges of esophageal tumors in patients before and after treatment to improve surgery and reduce the chance of cancer coming back.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT06408116 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endosonography, mpMRI, and PET/CT imaging in accurately determining the boundaries of esophageal tumors before and after neoadjuvant therapy and surgery. It aims to improve the precision of tumor delineation, which is crucial for effective treatment planning in patients with esophageal cancer. By enhancing the accuracy of tumor boundary identification, the study seeks to minimize the risk of cancer recurrence and improve surgical outcomes. The trial is conducted at the University Hospital Heidelberg in Germany, focusing on patients with specific types of esophageal cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus who are planned for surgical treatment.
Not a fit: Patients with distant metastasis, previous radiation therapy in the tumor region, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise treatment planning and improved outcomes for patients with esophageal cancer.
How similar studies have performed: While similar imaging techniques have been explored in other studies, this specific approach using PET imaging for esophageal cancer boundaries is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, including AEG I and AEG II tumors in the primary situation * Planned surgical treatment of esophageal carcinoma * Possible staging advantage through FAPI PET/CT diagnostics * Patient information and written consent -\> KI 60% or ECOG 0/1 (at least: self-sufficiency) * Age ≥ 18 years Exclusion Criteria: * Previous radiation therapy in the tumor region * Previous tumor disease with \< 5 years of remission * Surgical therapy is not functionally or technically possible * Distant metastasis * Patient is not capable of giving consent * Concurrent participation in another clinical trial that could affect the results of this trial or the other trial * Illnesses that do not allow the person concerned to assess the nature and scope as well as possible consequences of the clinical study * pregnant or breastfeeding women * Signs that the person taking part is unlikely to comply with the therapy (e.g. unwillingness to cooperate)
Where this trial is running
Heidelberg
- Department of Radiotherapy, University of Heidelberg — Heidelberg, Germany (RECRUITING)
Study contacts
- Study coordinator: Christoph Fink, MD
- Email: christoph.find.@med.uni-heidelberg.de
- Phone: +496221 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophagus Cancer, Stage I, Esophagus Cancer, Stage II