Clinical trial · Interventional
99mTc-3PRGD2 SPECT/CT in Esophagus Cancer Patients
Safety and Diagnostic Performance of 99mTc-3PRGD2 SPECT/CT in Esophagus Cancer Patients
- 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)
This is an open-label single photon emission computed tomography / computed tomography (SPECT/CT) study to investigate the safety and diagnostic performance of 99mTc-HYNIC-3PEG4-E\[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc-3PRGD2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Esophagus Cancer, 99mTc-3PRGD2, SPECT/CT
- description
- Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis of Esophagus cancer patients.
- interventionNames
- Drug: 99mTc-3PRGD2
Primary outcomes (2)
- measure
- Visual Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan
- timeFrame
- one year
- description
- Visual analysis will be performed by 3 experienced nuclear medicine physicians to observe the the uptake of 99mTc-3PRGD2 on esophagus lesions. The visual analysis interpreter's degree of suspicion for an abnormality was recorded with use of a 3-point with the following categories: score 1, no abnormal increased uptake; score 2, mildly increased uptake; score 3, definite focal increased uptake. The lesion was considered positive as malignancy if the lesion scored as 2 or higher.
- measure
- Semiquantitative Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females, ≥30 years old * Thoracic CT and/or gastroscopy diagnosis in suspicion of primary or recurrent lung cancer. * The lung cancer will be histologically confirmed or results of histology will be available. Exclusion Criteria: * Females planning to bear a child recently or with childbearing potential * Known severe allergy or hypersensitivity to IV radiographic contrast. * Inability to lie still for the entire imaging time because of cough, pain, etc. * Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. * Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
References
Publications (0)
Data not yet available