Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04615156
Other study ID # 231364
Secondary ID 231364
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date November 1, 2020
Est. completion date November 1, 2027

Study information

Verified date November 2020
Source Eastern Health, Canada
Contact Andrea Morgan, MNRN
Phone 709-777-1133
Email andrea.morgan@easternhealth.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study objectives are as follows: - To determine the safety of trial 18F-2-fluoro-2-deoxy-D-glucose, produced by a new manufacturer, by surveillance for adverse events in patients having Positron Emission Tomography Computed Tomography scans in a comprehensive program for indications including, but not limited to, oncology, neurology, cardiac and infectious/inflammatory processes. - To determine the efficacy of 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography in differentiating benign from malignant solitary pulmonary nodules and calculate sensitivity, specificity, and accuracy using pathologic confirmation as the gold standard when available, or greater than 6 month follow up stability on Computed Tomography scan when not. The purpose of performing this clinical trial is to provide local access of 18F-2-fluoro-2-deoxy-D-glucose to the patients of Newfoundland and Labrador. This product has been offered to patients over the last three years by transporting from facilities outside of the province. There have been significant delays in access and in fact, times where 18F-2-fluoro-2-deoxy-D-glucose has not been available through this process. This has caused delays and limitations of treatments for patients who rely on Positron Emission Tomography Computed Tomography scans for diagnosis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date November 1, 2027
Est. primary completion date November 1, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Known or suspected disease for which 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography Computed Tomography is appropriate for the investigation of. This includes, but is not limited to: Known or suspected cancer, neurological disorders (dementia or epilepsy), cardiac conditions (inflammation or myocardial viability), known or suspected presence of infection/inflammation process Patients must satisfy all the following: - Able to provide written informed consent, or consent obtained from appropriate guardian - Able to tolerate the physical and logistic requirements of completing a Positron Emission Tomography Computed Tomography scan Exclusion Criteria: - Pregnant women: if there is any possibility of pregnancy, a blood Beta Human Chorionic Gonadotropin level will be obtained as per Eastern Health policy. - Patients unwilling or unable to stop breast feeding for 12 hours - Patients who are too medically unstable to tolerate the uptake period or lie flat for the duration of the scan - Patients who exceed the safe weight limit of the Positron Emission Tomography Computed Tomography scanner bed (500 lbs.) or who cannot fit through the bore (70 cm diameter) - Patients unwilling to proceed with scan (I.e. claustrophobia) prior to injection - If patients inability to follow staff direction causes a safety hazard prior to injection

Study Design


Intervention

Drug:
18F-2-fluoro-2-deoxy-D-glucose
Administration of 18F-2-fluoro-2-deoxy-D-glucose for the purposes of diagnosis.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eastern Health, Canada

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring the safety of 18F-2-fluoro-2-deoxy-D-glucose produced by a new manufacturer by evaluating for any adverse events that occur during their Positron Emission Tomography Computed Tomography scan appointment. Evaluation for any adverse events after administration of 18F-2-fluoro-2-deoxy-D-glucose produced by Eastern Health in the Nuclear and Molecular Medicine Department who is a new manufacturer For the length of time required to perform informed consent, the scan, and follow-up interview for adverse events, approximately 4 hours
Secondary Evaluation of the sensitivity, specificity and accuracy of 18F-2-fluoro-2-deoxy-D-glucose in the assessment of solitary pulmonary nodules compared to anatomic pathology, or more than 6 month follow-up stability when not available. Assess the sensitivity, specificity and accuracy of 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography Computed Tomography in differentiating benign from malignant solitary pulmonary nodules. This is being done with a view towards eventually applying for an Abbreviated New Drug Submission. Variable, from the time of the scan to appropriate follow-up (either biopsy or follow-up imaging that occurs more than 6 months after the Positron Emission Tomography Computed Tomography study)
See also
  Status Clinical Trial Phase
Completed NCT01439152 - Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors. Phase 1
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Active, not recruiting NCT06015009 - Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers N/A
Active, not recruiting NCT03298100 - Risk Scoring Model for Endometrial Cancer
Recruiting NCT05055609 - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors Phase 1
Not yet recruiting NCT04324320 - Psychological Distress in Outpatient Oncological Rehabilitation
Completed NCT00588289 - Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA N/A
Recruiting NCT06222801 - The 1st Tumor CytokinoTherapy Database (TCTD-1)
Recruiting NCT03831633 - Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Phase 4
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting NCT05198570 - Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Recruiting NCT05712174 - A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer Phase 2
Recruiting NCT03832062 - Value of Analysing Under-utilised Leftover Tissue (VauLT)
Completed NCT03988777 - Magnetic Seed Localisation for Nonpalpable Breast Lesions
Recruiting NCT06031233 - Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie Phase 4
Enrolling by invitation NCT04019119 - Digital Intervention for the Modification of Lifestyles (iGame) N/A
Not yet recruiting NCT05926362 - Capillary-Venous Paired Data Collection
Recruiting NCT05510856 - Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients Phase 4
Recruiting NCT05686213 - ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial Phase 2
Completed NCT04180306 - PEWS Implementation in an LMIC Setting N/A