Clinical trial · Interventional
Clinic Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
NCT02441972CI-TRIAL-00026375unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.
Conditions
Conditions (6)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Carcinoma, Bronchogenic | Bronchogenic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Malignant | Lymphoma | ALIAS | 0.90 |
| Soft Tissue Neoplasms | Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Al-NOTA-PRGD2 PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-Al-NOTA-PRGD2 PET/CT
- description
- Imaging with 18F-Al-NOTA-PRGD2 PET/CT.
- interventionNames
- Drug: 18F-Al-NOTA-PRGD2 PET/CT
Primary outcomes (1)
- measure
- Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite)
- timeFrame
- 1 day
- description
- Safety data were collected before and after injection of 18F-Al-NOTA-PRGD2. physical examination; ECG; laboratory parameters (blood routine, liver function and kidney function) and adverse events.
Secondary outcomes (2)
- measure
- radioactive distribution of normal organ, standard uptake value of tumor
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Volunteers or patients with age more than 18 yeas; 2. The patients have been diagnosed with cancer or suspected with cancer; 3. It must fulfill the ethical requirements and subjects have signed an informed consent. Exclusion Criteria: 1. Pregnancy or nursing mothers; 2. Having drugs or alcohol dependence; 3. Hypersensitive to the active or inactive ingredients of the study drug; 4. Having attended other drug clinical trials within three months; 5. Cardiac functional insufficiency; 6. Hepatic and renal function insufficiency; 7. Hypertensive patients with serious complications; 8. Endangering the safety of life.
References
Publications (3)
- RESULTBeer AJ, Haubner R, Sarbia M, Goebel M, Luderschmidt S, Grosu AL, Schnell O, Niemeyer M, Kessler H, Wester HJ, Weber WA, Schwaiger M. Positron emission tomography using [18F]Galacto-RGD identifies the level of integrin alpha(v)beta3 expression in man. Clin Cancer Res. 2006 Jul 1;12(13):3942-9. doi: 10.1158/1078-0432.CCR-06-0266. PMID 16818691
- RESULTBeer AJ, Lorenzen S, Metz S, Herrmann K, Watzlowik P, Wester HJ, Peschel C, Lordick F, Schwaiger M. Comparison of integrin alphaVbeta3 expression and glucose metabolism in primary and metastatic lesions in cancer patients: a PET study using 18F-galacto-RGD and 18F-FDG. J Nucl Med. 2008 Jan;49(1):22-9. doi: 10.2967/jnumed.107.045864. Epub 2007 Dec 12. PMID 18077538
- DERIVEDWang L, Zhu X, Xue Y, Huang Z, Zou W, Zhang Z, Yu M, Pan D, Wang K. Ultrasensitive detection of uveal melanoma using [18F]AlF-NOTA-PRGD2 PET imaging. EJNMMI Res. 2024 Jul 5;14(1):62. doi: 10.1186/s13550-024-01123-4. PMID 38967722