Histologically-confirmed Malignancies Clinical Trial
Official title:
Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy
| NCT number | NCT02139150 |
| Other study ID # | 14-050 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | May 2020 |
| Verified date | September 2019 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to see if PET/CT scans that use a radioactive substance called [18F] fluorothymidine (FLT), can detect and monitor changes in the tumor. Radioactive substances are used with PET/CT scans to "see" cancer cells, and are also called radiotracers. FLT is a new radiotracer that has been given to people in prior studies. FLT PET/CT is an experimental scan unlike FDG (fluorodeoxyglucose) PET scan which is a standard clinical scan and is commonly used. The investigators would like to know if there is any evidence of early treatment response by obtaining FLTPET/ CT scans before and after treatment.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | May 2020 |
| Est. primary completion date | May 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with histologically-confirmed (confirmation done at MSKCC) malignancies. - Patients who have consented to a therapeutic protocol for the treatment of their cancer. - Patients must be = 18 years old. Exclusion Criteria: - Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia). - Women who are pregnant or breast-feeding. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change from pre- to posttreatment | We will describe the distribution of the change and explore if it is associated with the findings of standard-of-care imaging such as FDG-PET or CT/MRI using rank based methods such as Spearman correlation and the signed-ranks test. In addition we will also explore the value of the change in the FLT metrics in predicting the clinical outcome using logistic regression (for response) and proportional hazards regression (for progression and survival). | 4 years |