Clinical trial · Interventional
Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors
Multi-tracer PET Assessment of Response in Various Malignancies in Investigational and Recently Approved Therapeutic Agents
NCT01243333CI-TRIAL-00076128terminatedN/AResults 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)
This clinical trial studies multi-tracer positron emission tomography in patients with solid tumors. Diagnostic procedures, such as multi-tracer positron emission tomography, may help measure a patient's response to treatment.
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 |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [F-18]fluorodeoxyglucose | Radiation | — | UNRESOLVED |
| [F-18]fluorothymidine | Radiation | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Water O-15 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (multi-tracer PET scans)
- description
- Patients undergo Positron Emission Tomography (PET) scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
- interventionNames
- Radiation: [F-18]fluorodeoxyglucose
- Radiation: [F-18]fluorothymidine
- Procedure: Positron Emission Tomography
- Radiation: Water O-15
Primary outcomes (3)
- measure
- FDG Therapeutic Response
- timeFrame
- 1-2 cycles of treatment - approximately one month
- description
- The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \[F-18\]fluorodeoxyglucose (FDG) and \[F-18\]fluorothymidine (FLT). The percent change in the SUVmax for FDG was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible adult patients currently meeting inclusion criteria and will be treated with an investigational or recently approved therapeutic agent at HCI; the patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; RECIST imaging must be current and have been obtained within 30 days prior to the baseline imaging session * Patients must document their willingness to be followed for a period of time; for the purposes of imaging data analysis this will ideally be for at least 12 months after completing the investigational or recently approved therapy, however this may not always be possible; by signing informed consent, the patients are documenting their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database * All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines * Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans; the serum pregnancy test must be performed within 48 hours prior to research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging * Serum glutamic oxaloacetic transaminase (SGOT) less than 4.0 times below or above the upper or lower limit range * Serum glutamate pyruvate transaminase (SGPT) less than 4.0 times below or above the upper or lower limit range * Alkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit range * Lactate dehydrogenase (LDH) less than 4.0 times below or above the upper or lower limit range * Total bilirubin less than 4.0 times below or above the upper or lower limit range * Serum electrolytes less than 4.0 times below or above the upper or lower limit range * Complete blood count (CBC) with platelets less than 4.0 times below or above the upper or lower limit range * Prothrombin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time must not exceed 6 times the upper limit of the normal range * Partial thromboplastin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for partial thromboplastin time must not exceed 6 times the upper limit of the normal range * Blood urea nitrogen (BUN) less than 4.0 times below or above the upper or lower limit range * Creatinine less than 4.0 times below or above the upper or lower limit range * Urinalysis less than 4.0 times below or above the upper or lower limit range; urinalysis abnormalities will not preclude the patient from being enrolled and studied Exclusion Criteria: * Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals; patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion * Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile * Adult patients who require monitored anesthesia for PET scanning * Patients known to be human immunodeficiency virus (HIV) positive
References
Publications (0)
Data not yet available
No reference posted for this study.