Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas

Toulouse University Hospital

Status and phase: Terminated; Phase 2

Conditions: Rectal Adenocarcinoma

Treatments: Procedure: Pelvic MRI and F MISO TEP

Study type: Interventional

Funder types: Other

Identifiers

NCT01619696

0932103

Details and patient eligibility

About

The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

Full description

The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.

Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.

Exclusion criteria

• synchonous metastatis
• previous malignant tumour
• previous radiotherapy/ chemotherapy
• performance status WHO>2
• contraindication to 5 FU

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

3 participants in 1 patient group

Intervention

Experimental group

Treatment:

Procedure: Pelvic MRI and F MISO TEP