Clinical trial · Observational
PERCIST Criteria for Response Evaluation With Solid Tumors
PERCIST Criteria for Response Evaluation of Non-surgical Therapy in Patients With Solid Tumors:Prospective Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chemo-radiotherapy and targeted therapy are widely used as non-surgical treatments for solid tumors. Early assessment of treatment response is considered efficient and helpful to clinical management and personalized therapy.RECIST 1.1 criteria was accepted widely. Complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) are defined in the RECIST criteria. This type of classification divides intrinsically continuous data (tumor size) into 4 bins, losing statistical power for ease of nomenclature and convenience. The 18F-FDG PET exam is based on metabolic information and considered to overcome limitations of anatomic imaging and more suitable for assessment of therapeutic response.PERCIST 1.0 proposes a series of detailed and unambiguous regulations about standardization procedures to ensure the reproducibility. Complete metabolic response (CMR), partial metabolic response (PMR), stable metabolic disease (SMD), and progressive metabolic disease (PMD) are defined in the PERCIST criteria. So far, there have several studies using metabolic-based PERCIST criteria in patients with solid tumors, including lung cancer, digestive tumor and lymphoma, etc. But all of these studies had limitations of small study sample, thus were need to be further investigated. Compared to RECIST, the advantages of PERCIST were to evaluate chemotherapy, especially targeted therapy, to distinguish PMR and SMD patients from SD group in RECIST, and to better predict the response rate. Recently, several studies applied PERCIST criteria to evaluate neoadjuvant chemotherapy in pancreatic cancer and rectal cancer, and revealed the metabolic response results were well related to pathology. All these studies conclude PERCIST criteria could help making clinical therapeutic decisions. Moreover, several studies have shown that PERCIST has advantage in predicting early response of several malignant tumors. The aim of this multicenter study is 1) to evaluate treatment response in newly diagnosed and pre-therapeutic patients with solid tumors who are going to receive a baseline , an early follow-up (after a certain period of treatment cycle) and a final (after treatment) 18F-FDG PET/CT; 2) to compared PERCIST criteria to RECIST 1.1 criteria in prediction treatment response, especially in early stage of treatment; 3) to reveal the value of PERCIST criteria in clinical therapeutic management and tailed therapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| drug&radiation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- drug
- description
- Early treatment response assessment: using baseline data and early follow-up data Evaluate treatment response: using baseline data, early follow-up data and final data Compare PERCIST to RECIST criteria: correlation analysis Evaluate prognostic value: using baseline data, early follow-up data, final data as well as follow up PFS and OS time (Kaplan-Meier survival plot
- interventionNames
- Other: drug&radiation
- label
- radiation
- description
- Early treatment response assessment: using baseline data and early follow-up data Evaluate treatment response: using baseline data, early follow-up data and final data Compare PERCIST to RECIST criteria: correlation analysis Evaluate prognostic value: using baseline data, early follow-up data, final data as well as follow up PFS and OS time (Kaplan-Meier survival plot
- interventionNames
- Other: drug&radiation
Primary outcomes (2)
- measure
- Evaluate treatment response by PERCIST to RECIST 1.1 criteria in early stage of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 30-80 years old ( might differ based on certain cancer type) * Newly diagnosis of solid tumor proved by imaging * Pathology proved to be primary solid tumor * First PET/CT scan was performed before any kinds of anti-tumor treatment including surgery * No other anti-tumor treatments except for that required during the trial * Written and informed consent with signature before the study * Complete medical history and clinical record (including physical examination, electrocardiogram, hematology, biochemistry, tumor pathology etc) * Follow-up of PSF and OS over a year Exclusion Criteria: * Pregnancy, lactation, and impaired renal or liver function * Receive additional anti-tumor treatments (including surgery) other than that required during the trial * Poorly controlled diabetes * Poor compliance * Failed to perform scans * Contrary to the standard operating procedures * Without a definite pathologic diagnosis or follow-up results * Not suitable for clinical trials (for example with mental illness)
References
Publications (0)
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