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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02233595
Other study ID # 144513
Secondary ID NCI-2015-00980
Status Terminated
Phase
First received
Last updated
Start date October 15, 2014
Est. completion date January 28, 2018

Study information

Verified date August 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date January 28, 2018
Est. primary completion date January 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- A diagnosis of histopathologically confirmed rectal adenocarcinoma.

- Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.

- Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.

- Age =18.

- Ability to understand a written informed consent document and the willingness to sign it.

- Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at Univeristy of California, San Francisco (UCSF).

- Neoadjuvant chemoradiation prior to resection is planned..

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion Criteria:

- ERUS tumor state of T1.

- Radiographic evidence of metastatic disease

- Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.

- Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)

- Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.

- Prior history of pelvic radiation.

- Uncontrolled hyperglycemia (defined as inability to achieve a glucose of <250 mg/dL at time of fluorodeoxyglucose (FDG) injection).

- Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) < 30 mLs/min), which is a contraindication to gadolinium containing contrast.

- Known allergy to gadolinium containing contrast agents.

- Contraindication to use of fluoropyrimidines as a radiosensitizing agent.

- Pregnancy or nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. This is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Chemoradiation


Locations

Country Name City State
United States UCSF Imaging Center at China Basin San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in SUVmax To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response 2 months
Primary tumor volume To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response 2 months
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