Gadodiamide
| 證據等級: L5 | 預測適應症: 2 個 |
目錄
Gadodiamide: From MRI Contrast Imaging to Rheumatoid Arthritis
One-Sentence Summary
Gadodiamide (DrugBank DB00225) is a gadolinium-based paramagnetic contrast agent used to enhance MRI imaging; it is not currently marketed in Taiwan and has no on-file therapeutic indication. The TxGNN model predicts it may be effective for Rheumatoid Arthritis, but this is supported by 0 clinical trials and 10 publications, all of which describe using gadodiamide as an imaging tool to visualize joint inflammation — not as a treatment. The drug’s own repurposing rationale flags this as a likely false positive: the model appears to have mistaken “used diagnostically in RA patients” for “treats RA.”
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not on file — no Taiwan license records exist; publicly known globally as an MRI contrast agent (not a therapeutic drug) |
| Predicted New Indication | Rheumatoid Arthritis |
| TxGNN Prediction Score | 99.16% |
| Evidence Level | L5 |
| US Market Status | Not Marketed |
| Number of NDAs | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for gadodiamide from the standard data sources queried. Based on known information, gadodiamide is a gadolinium-based paramagnetic MRI contrast agent — its pharmacological action is to shorten proton T1 relaxation time to enhance image contrast. It has no known anti-inflammatory, immunomodulatory, or synovial-pathology-related pharmacology.
The literature link to rheumatoid arthritis comes entirely from a diagnostic context: contrast-enhanced MRI is a well-established method for visualizing synovitis and pannus in RA patients, so gadodiamide co-occurs frequently with RA in the literature simply because it is the imaging agent used to study the disease, not to treat it.
Given this, the evidence pack’s own assessment concludes there is no credible mechanistic basis for a treatment hypothesis, and classifies this as a likely case of the TxGNN model conflating “diagnostic co-occurrence” with “therapeutic association.” The same reasoning applies to the second-ranked candidate, osteoarthritis susceptibility, which has no supporting literature or trials at all.
Clinical Trial Evidence
Currently no related clinical trials registered
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 17935920 | 2009 | Methodology/Imaging | European journal of radiology | Distribution pattern of ultrasound-guided intra-articular injection in RA wrist joints |
| 18286282 | 2008 | Diagnostic imaging | Skeletal radiology | Contrast-enhanced MRI analysis of hands/wrists in psoriatic arthritis |
| 17289759 | 2008 | Diagnostic imaging | Annals of the rheumatic diseases | MRI and bone scintigraphy for differential diagnosis of unclassified arthritis |
| 17340197 | 2007 | Methodology | Annals of biomedical engineering | Kinetic modeling of contrast-enhanced MRI to assess RA wrist inflammation |
| 11454641 | 2001 | Diagnostic imaging | Annals of the rheumatic diseases | Low-field dedicated MRI in untreated recent-onset RA |
| 11976868 | 2002 | Diagnostic imaging | European radiology | MRI features predicting bone erosion progression at 1-year follow-up |
| 11669155 | 2001 | Diagnostic imaging | The Journal of rheumatology | MRI of wrist/finger joints across inflammatory joint disease groups |
| 11419149 | 2001 | Methodology | European radiology | Comparison of low-field extremity MRI vs high-field MRI in arthritic small joints |
| 11868082 | 2002 | Methodology | European radiology | Synovial membrane volume: manual vs stereologic MRI measurement methods |
| 11274835 | 2001 | Diagnostic imaging | European journal of radiology | Gadolinium enhancement patterns at atlantoaxial joints in normal subjects |
Note: All 10 publications describe gadodiamide-enhanced MRI as an imaging/diagnostic tool for assessing joint disease — none evaluate gadodiamide as a therapeutic agent for RA.
US Market Information
Not currently marketed in Taiwan — no license records on file (0 NDAs).
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: There is no mechanistic basis, no clinical trial evidence, and no treatment-related literature supporting gadodiamide as a therapy for rheumatoid arthritis — all identified literature reflects its use as an imaging contrast agent, not a drug candidate. The second candidate (osteoarthritis susceptibility) is even weaker, with zero supporting trials or publications. Both should be treated as likely false-positive predictions arising from diagnostic co-occurrence in the underlying knowledge graph rather than genuine drug-repurposing signals.
To proceed, the following is needed:
- TFDA/FDA package insert data (warnings, contraindications) — currently blocking even a baseline safety review
- Confirmed mechanism of action data from DrugBank
- Independent pharmacological rationale for any anti-inflammatory or immunomodulatory activity, if this candidate is to be pursued further
- Given the diagnostic-vs-therapeutic confound identified here, consider flagging this candidate type (imaging/diagnostic agents predicted against disease-with-imaging-literature) for automatic down-weighting in future TxGNN evidence packs
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.