Clinical trial · Interventional
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
A Test-retest Study to Assess Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of AH111585 (18F) Injection.
NCT00918281CI-TRIAL-00014801completedPhase 2Results postedClinicalTrials.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)
Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.
Conditions
Conditions (7)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| High Grade Gliomas | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluciclatide Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluciclatide Injection
- description
- Fluciclatide Injection
- interventionNames
- Drug: Fluciclatide Injection
Primary outcomes (1)
- measure
- Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.
- timeFrame
- Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.
- description
- Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.
Secondary outcomes (1)
- measure
- The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has been diagnosed with at least one solid primary or metastatic tumor greater than 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, breast and H\&N cancers. * The subject has received clinical routine imaging diagnostic work-up within 8 weeks prior to the first \[18F\]AH111585 PET scan. * The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care. Exclusion Criteria: * The subject has known hyper- or hypo-coagulation syndromes. * The subject has received chemotherapy within 3 weeks, or received radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to the first \[18F\]AH111585 PET scan. * The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer between the first and second \[18F\]AH111585 PET scans. * The subject is scheduled to undergo biopsy for the target tumour between the first and second \[18F\]AH111585 PET scans. * The subject has intra-hepatic tumour(s) only. * For the immuno-histochemistry group, the subject's target tumour has been biopsied less than or equal to 1 week prior to the first \[18F\]AH111585 PET scan.
References
Publications (0)
Data not yet available
No reference posted for this study.