Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03426865
Other study ID # STU 032017-051
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date July 5, 2024

Study information

Verified date November 2023
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.


Description:

Investigators aim to perform a prospective study of anti-18F-FACBC PET/CT in patients with NSGCT prior to RPLND, either in the primary setting or in the post-chemotherapy setting. We will correlate histopathologic outcomes from the RPLND specimen and clinical outcomes of recurrence during follow-up to identify the accuracy of anti-18F-FACBC PET/CT in these settings.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date July 5, 2024
Est. primary completion date July 5, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with histologically confirmed NSGCT after orchiectomy who are scheduled to undergo primary RPLND or post-chemotherapy RPLND - Patients must be over 18 years old and capable and willing to provide informed consent. - Medically stable as judged by patient's physician. - Life expectancy must be estimated at > 6 months. - Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age >70 years). - Patient must be able to lie still for a 20 to 30 minute PET/CT scan. Patients will be asked if they have problems or issues with lying flat Exclusion Criteria: - Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to anti-18F-FACBC are NOT eligible. - Patients with liver failure are NOT eligible. - Patients currently undergoing chemotherapy or chemotherapy within two weeks of anti-18F-FACBC PET/CT scan are NOT eligible

Study Design


Intervention

Drug:
Axumin PET scan
PET scan prior to RPLND

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes Two years
See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Completed NCT00002596 - Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Phase 3
Not yet recruiting NCT03448822 - Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
Completed NCT01433224 - Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression N/A
Recruiting NCT01172912 - High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy Phase 2
Completed NCT00293384 - Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant N/A
Active, not recruiting NCT00003643 - Combination Chemotherapy in Treating Men With Germ Cell Cancer Phase 2/Phase 3
Completed NCT00019331 - Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors Phase 2
Completed NCT00003107 - Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors Phase 1
Completed NCT00002515 - Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer Phase 2
Recruiting NCT06133699 - Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors N/A
Recruiting NCT05670938 - Follow-up After Surgery for Testicular Cancer
Active, not recruiting NCT00104676 - Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors Phase 3
Recruiting NCT00551122 - Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors Phase 1/Phase 2
Completed NCT00002508 - Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors Phase 1/Phase 2
Completed NCT00003800 - Diagnostic Study of Patients With Stage I Testicular Cancer N/A
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Completed NCT00007813 - Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Phase 1