Radiomics of Immunotherapeutics Response Evaluation and Prediction

Solid Tumor Clinical Trial

— RIREP  

Official title:

Radiomics of Immunotherapeutics Response Evaluation and Prediction in Solid Tumor: A Multicenter Diagnostic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079283
• Other study ID #: IIT0100
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: February 25, 2020

Study information

• Verified date: June 2019
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the feasibility and efficiency of CT radiomic analysis which serves as a high through-put analytical strategy applied to image big-data resource in evaluating and predicting the response of immunotherapeutics. A multi-center retrospective diagnostic test has been designed for this aim to compare the predictive performance of clinical model, qualitative model incorporating semantic CT features and image-based quantitative radiomic model. The reference standard of therapeutic effect is determined by the latest evaluation result utilizing iRECIST within 365 days after recruited. This study intends to enroll 400 participates who had been diagnosed with advanced somatic solid tumor confirmed by histo- or cyto-pathological examination and were planning to receive immunotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: February 25, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with histopathological or cytopathological confirmed solid tumor (including metastatic solid tumor).

2. Patients = 18 years of age on the day of baseline CT scan.

3. Patients received immune checkpoint inhibitors (ICI) monotherapy or combined with chemotherapy in any line of treatment.

4. Patients with at least one measurable target lesion of which minor axis was greater than 15mm and without any local treatment.

5. Female with a negative pregnancy test, or male who agree to use barrier methods of contraception through the therapy period.

6. Patients with a Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1.

7. Patients underwent follow-up CT scans with an 6-9-week interval until 365 days after baseline CT scan.

8. Patients with baseline and follow-up CT scans which meet the following conditions: a) Spiral computed tomography device of General Electric Healthcare or Siemens with greater than 16 rows of detectors ; b) Peak kilovoltage: 120kV; c) Dose: auto or fixed; d) Slice resolution: not less than 512 pixels multiply 512 pixels; e) Scanning range: from supraclavicular region to 2cm below the costophrenic angle for thorax, and from diaphragm to pubic symphysis for abdomen; f) contrast-enhanced scan utilizing nonionic low- or iso-osmolar contrast agent and including arterial phase, venous phase and delayed phase at least.

Exclusion Criteria:

1. Patients received any kinds of cytotoxic drugs or experimental drugs 2 weeks before enrollment.

2. Patients meet the contraindications of contrast-enhanced CT scan.

3. Patients who were not suitable for continuous follow-up CT scans.

4. Patients with severe myocardial infarction confirmed by ECG or left ventricular ejection fraction(LVEF) less than 40% or glomerular filtration rate(GFR) less than 45ml/min.

5. Patients who cannot tolerate immunotherapy or with serious immune-related adverse response.

6. Patients with severe interstitial pneumonia confirmed by baseline CT scan.

7. Patients who cannot complete follow-up examinations scheduled by study design.

8. Patients with AIDS or positive serum HIV antibodies.

9. Patients with a CT scan presenting extremely low signal noise ratio or too much artifacts at any timepoint.

Related Conditions & MeSH terms

• Predictive Cancer Model
• Solid Tumor

Intervention

Diagnostic Test:
• Clinical
Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)
• Semantic
Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)
• Radiomic
Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute And Hospital	Tianjin	Tianjin

Sponsors (10)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital Xi'an Jiaotong University, Hubei Cancer Hospital, Liaoning Tumor Hospital & Institute, Shandong Tumor Hospital, Sun Yat-sen University, Tianjin Chest Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the receiver operating characteristic curve (ROC)	Area under curve (AUC) of each diagnostic model	6 months and 1 year since course start (365 days)
Secondary	Disease Control Rate	Disease Control Rate of immunotherapy	6 months and 1 year since course start (365 days)
Secondary	Incidence	Incidence of immune-related adverse events	Through study completion, an average of 1 year