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Total Neo-adjuvant Therapy, 18FDG-PET/MRI scan · 1 trial · 1 indication
A 3-point scale will be used on PET/MRI assessment. When PET and MRI are concordant, the score remains unchanged. When MRI or PET are discordant, but one modality is definitive for complete response (e.g., MRI showing low intensity crescent at site of tumor or no uptake is identified on corresponding location on PET), a tumor regression grade (TRG) score of 1 will be assigned.
The pathologic response to the total neo-adjuvant therapy will be assessed generally using classification of tumor regression grade (TRG) defined by Mandard et al.
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | All patients receive total neo-adjuvant therapy (TNT), depending on institutional policy |
| Name | Type | Description |
|---|---|---|
| Total Neo-adjuvant Therapy | RADIATION | * TNT incorporates chemotherapy with concurrent chemoradiotherapy (CRT) in any order. * Radiotherapy includes 5000 cGy/25 fractions over 5 weeks. * Chemotherapy regimen for Concurrent CRT: Capecitabine * Chemotherapy regimens used with TNT are: FOLFIRINOX x 6 cycles, 8-9 courses FOLFOX or 5-6 courses of CAPEOX delivered over 4-6 months. * The chemotherapy regimen or the order of treatment will be decided at the discretion of the patient's medical oncologist |
| 18FDG-PET/MRI scan | OTHER | 18FDG-PET/MRI scan within 4 weeks of commencing chemo-radiation and within 1 - 2 weeks before radical rectal cancer surgery. |
Inclusion Criteria: 1. Patients with histologically proven adenocarcinoma of the rectum. 2. Clinical stage 2-3 rectal adenocarcinoma, cT3/4N0/M0 or Tx N1-2/M0, within 16 cm from anal verge (lesion below the sacral promontory). 3. Patients deemed suitable to undergo TNT followed by surgical resectio...
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Total Neo-adjuvant Therapy, 18FDG-PET/MRI scan is an investigational imaging approach being studied for use in rectal cancer. It combines total neoadjuvant therapy with 18FDG-PET/MRI scanning to evaluate the disease. The therapy is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Total Neo-adjuvant Therapy, 18FDG-PET/MRI scan is being developed by Avalon GloboCare Corp., a biopharmaceutical company. The company is conducting clinical trials to evaluate this therapy in patients with rectal cancer. Avalon GloboCare Corp. is publicly traded under the ticker symbol ALBT.
Total Neo-adjuvant Therapy, 18FDG-PET/MRI scan is currently in Phase 2 clinical development. It is an investigational therapy for rectal cancer and has not yet received FDA approval. The therapy is still being studied in clinical trials to assess its safety and effectiveness.
Total Neo-adjuvant Therapy, 18FDG-PET/MRI scan is being evaluated in a Phase 2 clinical trial with the identifier NCT06057831. This trial, titled 'PET/MRI in Rectal Cancer,' is not yet recruiting and plans to enroll 40 participants. The study is designed to assess the therapy in patients with rectal cancer.
No, Total Neo-adjuvant Therapy, 18FDG-PET/MRI scan is not FDA approved. It is an investigational therapy currently in Phase 2 clinical trials for rectal cancer. The therapy is still under clinical investigation and has not been approved for commercial use by the FDA or any other regulatory authority.