Clinical trial · Interventional
Fludeoxyglucose F 18 PET/CT Imaging in Finding Cancer in Patients Undergoing Surgery for Solid Tumors
Pilot Study Evaluating a Combined and Integrated Technological Approach of F-18-FDG-Directed Perioperative PET/CT Imaging and Intraoperative Handheld Gamma Prove Detection of Known and Occult Disease in Patients Undergoing Surgery for Solid Malignancies
- 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 pilot study is to evaluate a combined and integrated technological approach of 18F-FDG-directed perioperative PET/CT imaging and intraoperative handheld gamma probe detection of known and occult disease in patients undergoing surgery for solid malignancies.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG for patients with Bladder Cancer | Drug | — | UNRESOLVED |
| 18F-FDG Injection | Drug | — | UNRESOLVED |
| PET/CT scan | Procedure | — | UNRESOLVED |
| Preoperative 18F-FDG PET/CT Scan | Procedure | — | UNRESOLVED |
| Specimen PET/CT Scan | Procedure | — | UNRESOLVED |
| Surgical Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- F-FDG-directed surgery for known or suspected malignancy using gamma detection probes.
- interventionNames
- Procedure: PET/CT scan
- Drug: 18F-FDG Injection
- Procedure: Preoperative 18F-FDG PET/CT Scan
- Drug: 18F-FDG for patients with Bladder Cancer
- Procedure: Surgical Procedure
- Procedure: Specimen PET/CT Scan
Primary outcomes (1)
- measure
- Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy.
- timeFrame
- up to five years
Secondary outcomes (6)
- measure
- Evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify resection of disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be 18 years of age or older. * Patients must either have a histologic-confirmed solid malignancy or have a suspected solid malignancy which has required a diagnostic preoperative PET/CT scan or for which a diagnostic preoperative PET/CT scan has been recommended * Patients must clinically have been determined to be a candidate for the indicated surgical procedure. * Patients may have had prior surgery and/or chemotherapy with no limit to the number of prior therapeutic procedures or chemotherapeutic regimens. * Patients must have a performance status of 0, 1 or 2 by ECOG standards. * Patients must give written informed consent, including consent to have IV line placed for 18F-FDG administration. * Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilization, or must give history of no menses in past twelve months. * Fasting blood sugar less than 200 mg/dl. Exclusion Criteria: * Any patient with active CNS tumor involvement. * Any patient who is pregnant or lactating. * Any patient with a body size and habitus that is determined to prohibit use of the diagnostic equipment. * Any patient with a tumor burden that is determined to be so great (as determined by preoperative PET/CT scanning or intraoperative findings) that further surgery is not advised.
References
Publications (1)
- RESULTPovoski SP, Chapman GJ, Murrey DA Jr, Lee R, Martin EW Jr, Hall NC. Intraoperative detection of (1)(8)F-FDG-avid tissue sites using the increased probe counting efficiency of the K-alpha probe design and variance-based statistical analysis with the three-sigma criteria. BMC Cancer. 2013 Mar 4;13:98. doi: 10.1186/1471-2407-13-98. PMID 23496877