Clinical trial · Interventional
An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.
An Exploratory Evaluation of Technetium Tc 99m Tilmanocept by Intravenous (IV) Injection in Subjects With Liver Metastases From Colorectal Carcinoma Patients Using SPECT/CT Imaging Compared to Fluorodeoxyglucose (FDG) PET/CT Imaging.
NCT03029988CI-TRIAL-00047088terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of effect in Cohort 1
Summary
Brief summary (as posted)
Estimation of the concordance of Tc 99m localization in liver metastases from colorectal carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPECT/CT Imaging | Procedure | — | UNRESOLVED |
| Tilmanocept (Technetium Tc 99m tilmanocept Injection) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection.
- interventionNames
- Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection)
- Procedure: SPECT/CT Imaging
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Subjects will receive 200 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection. If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data.
- interventionNames
- Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection)
- Procedure: SPECT/CT Imaging
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has provided written informed consent with Health Information Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures. * Subjects must be ≥18 years old; * The subject must have a diagnosis of adenocarcinoma of the colon and/or rectum with FDG PET/CT confirmed metastases to the liver; * The subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3; * The subject must be at least 4 weeks past any major intraabdominal surgery, including surgery to the liver; * Subjects with prior malignancies other than colon and/or rectum cancer are allowed, provided they have been treated with curative intent, and have no evidence of recurrence of that malignancy; * Each subject must have no more than 10 qualifying liver lesions that have been clinically confirmed metastatic adenocarcinoma of the colon by FDG PET/CT imaging. * If of childbearing potential, the subject has a negative urine pregnancy test within 48 hours before administration of Tc 99m Tilmanocept, has been surgically sterilized, or has been postmenopausal for at least 1 year Exclusion Criteria: * The subject is pregnant or lactating. * The subject has undergone any liver surgery, exclusive of a biopsy. * The subject has known sensitivity to dextran. * The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 10 days prior to Tc 99m Tilmanocept administration * Before the administration of Tc 99m Tilmanocept, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical * Has received an investigational product within the 30 days prior to Tc 99m Tilmanocept administration
References
Publications (0)
Data not yet available
No reference posted for this study.