NCT06189898 Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
| NCT ID | NCT06189898 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sebastian Zschaeck |
| Condition | Esophagus Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2023-12-15 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial on biomarker validation investigates the use of innovative re-staging FDG-PET parameters to detect highly chemoradiation (CRT) sensitive squamous cell carcinomas of the esophagus (SCEC) at the end of preoperative or definitive CRT.
Eligibility Criteria
Inclusion Criteria: * patients with squamous cell, undifferentiated or adenocarcinoma of the esophagus, UICC stage II-IVA (maximum T4a) * ECOG performace status 0-2 * Complete clinical staging, including, esophagogastroscopy, EUS, CT neck/thorax/abdomen and adequate pulmonary function. * Adequate hematological, renal, hepatic and pulmonary functions defined as: granulocytes ≥ 1.5 x 109/l platelets ≥ 100 x 109/l total bilirubin ≤ 1.5 x upper normal limit creatinine ≤ 120 μmol/L FEV1 ≥ 1.5 L * Written, voluntary informed consent * Willingness to perform effective contraceptive practices during treatment for patients with childbearing potential Exclusion Criteria: * Evidence of distant metastases (cM1) * Prior high-dose radiotherapy to the thorax or abdomen * Primary tumor cT4b * history or concurrent malignancy as judged by the treating physician. This is only an exclusion criterion if the other malignancy is considered the oncological potentially leading cause of death compared to the esophageal cancer.
Contact & Investigator
Sebastian Zschaeck, MD
PRINCIPAL INVESTIGATOR
Charite University, Berlin, Germany
Frequently Asked Questions
Who can join the NCT06189898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophagus Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06189898 currently recruiting?
Yes, NCT06189898 is actively recruiting participants. Contact the research team at sebastian.zschaeck@charite.de for enrollment information.
Where is the NCT06189898 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT06189898 clinical trial?
NCT06189898 is sponsored by Sebastian Zschaeck. The principal investigator is Sebastian Zschaeck, MD at Charite University, Berlin, Germany. The trial plans to enroll 48 participants.
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