68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy

NCT05999227 | Unknown

• 1 other identifier: XLan-0379
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET imaging in early response evaluation of rectal cancer patients treated with immunotherapy. Patients with histopathologically confirmed diagnosis of rectal cancer will be recruited and undergo 68Ga-FAPI-04 and 18F-FDG PET imaging before treatment and after short-course radiotherapy and two cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart. The efficacy of 68Ga-FAPI-04 in early response evaluation will be compared with the general imaging agent 18F-FDG. The general information, clinical data, mpMRI data, 68Ga-FAPI-04 and 18F-FDG PET imaging results and other imaging data of the patients will be collected. The histopathology of the biopsy or surgical specimen after 2 cycles of therapy and follow-up data will be taken as evaluation references. This study plans to set the sample size as 20 cases

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• 68Ga-FAPI-04 PET analysis

  PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.

  Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)

• 18F-FDG PET analysis

  PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.

  Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)

Study Arms (1)

Immunotherapy

EXPERIMENTAL

Patients with rectal cancer will receive short-course radiotherapy and neoadjuvant chemotherapy plus immunotherapy. 68Ga-FAPI-04 and 18F-FDG PET will be performed at baseline and after short-course radiotherapy and 2 cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart.

Drug: 68Ga-FAPI-04; Drug: 18F-FDG

Interventions

68Ga-FAPI-04 DRUG

A fibroblast activation protein (FAP) -targeted PET imaging agent

Also known as: 68Ga-FAPI

Immunotherapy

18F-FDG DRUG

A general glucose metabolism imaging agent

Also known as: 18F-fluorodeoxyglucose

Immunotherapy

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed T3-4N0M0 or T1-4N+M0 (according to the 8th edition of the International Union Against Cancer TNM staging system) rectal adenocarcinoma and treatment naïve;
• No severe hematologic, cardiac, pulmonary, hepatic, or renal functional abnormalities or immunodeficiency diseases;
• An Eastern Cooperative Oncology Group Performance Status of 0-1;
• Patients who agree to undergo 68Ga-FAPI-04 and 18F-FDG PET imaging.

You may not qualify if:

• Any experiences of anti-programmed death ligand 1 (PD-L1) or anti-PD-1 antibody treatment;
• A history of pelvic radiation;
• The presence of autoimmune disease;
• Hypersensitive to any monoclonal antibodies;
• History of interstitial lung disease;
• Active and uncontrolled infection.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

China, Hubei Province

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

68Ga-FAPI; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Xiaoli Lan

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Central Study Contacts

Xiaoli Lan

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 21, 2023
• Study Start: June 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-06

Locations

CN (1)