[18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal Cell Carcinoma

NCT06428708 | Recruiting Early Phase 1

• 1 other identifier: ReDA 11465
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Keywords

PSMA PET; Metastatic clear cell renal cell carcinoma; [18F]PSMA-1007; PSMA

Outcome Measures

Primary Outcomes (2)

• Number of metastatic lesions

  To identify additional metastatic lesions that may not be apparent on conventional cross-sectional imaging during the initial staging process.

  5 weeks from initial baseline conventional imaging

• Change in management

  To determine the proportion of patients in which results from the PSMA-PET imaging changes management.

  1 month

Secondary Outcomes (1)

• Pathologic correlates

  1 month or not applicable

Study Arms (1)

[18F] PSMA-1007 PET/CT

EXPERIMENTAL

All patients enrolled undergo a \[18F\] PSMA-1007 PET/CT

Diagnostic Test: [18F] PSMA-1007 PET/CT

Interventions

[18F] PSMA-1007 PET/CT DIAGNOSTIC_TEST

\[18F\] PSMA-1007 PET/CT scan

[18F] PSMA-1007 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with histologically-proven, metastatic renal cell carcinoma (RCC)(TNM stage Tany, Nany, M1)
• Must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced CT or MRI within 5 weeks of enrolment. Contrast is required unless the participant cannot for medical reasons (ie renal failure).
• Exception: Unenhanced CT of the chest is acceptable Exception: Unenhanced MRI of abdomen and pelvis is acceptable in cases of renal failure

You may not qualify if:

• Pregnant or breastfeeding
• Age less than 18
• Histology does not have any clear cell component
• Unable to lie flat for 30 minutes for the scan
• History of prior malignancy (except non-melanoma skin cancer)
• Unable to provide informed consent
• Inadequate liver function
• Systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before PSMA scan can take place
• Previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer)

Sponsors & Collaborators

• Western University: lead

Study Sites (1)

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A5W9, Canada

RECRUITING

Related Publications (14)

• Mittlmeier LM, Unterrainer M, Rodler S, Todica A, Albert NL, Burgard C, Cyran CC, Kunz WG, Ricke J, Bartenstein P, Stief CG, Ilhan H, Staehler M. 18F-PSMA-1007 PET/CT for response assessment in patients with metastatic renal cell carcinoma undergoing tyrosine kinase or checkpoint inhibitor therapy: preliminary results. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):2031-2037. doi: 10.1007/s00259-020-05165-3. Epub 2020 Dec 28.

  PMID: 33369689 BACKGROUND

• Giesel FL, Hadaschik B, Cardinale J, Radtke J, Vinsensia M, Lehnert W, Kesch C, Tolstov Y, Singer S, Grabe N, Duensing S, Schafer M, Neels OC, Mier W, Haberkorn U, Kopka K, Kratochwil C. F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):678-688. doi: 10.1007/s00259-016-3573-4. Epub 2016 Nov 26.

  PMID: 27889802 BACKGROUND

• Rhee H, Blazak J, Tham CM, Ng KL, Shepherd B, Lawson M, Preston J, Vela I, Thomas P, Wood S. Pilot study: use of gallium-68 PSMA PET for detection of metastatic lesions in patients with renal tumour. EJNMMI Res. 2016 Dec;6(1):76. doi: 10.1186/s13550-016-0231-6. Epub 2016 Oct 22.

  PMID: 27771904 BACKGROUND

• Yin Y, Campbell SP, Markowski MC, Pierorazio PM, Pomper MG, Allaf ME, Rowe SP, Gorin MA. Inconsistent Detection of Sites of Metastatic Non-Clear Cell Renal Cell Carcinoma with PSMA-Targeted [18F]DCFPyL PET/CT. Mol Imaging Biol. 2019 Jun;21(3):567-573. doi: 10.1007/s11307-018-1271-2.

  PMID: 30218388 BACKGROUND

• Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30.

  PMID: 31147927 BACKGROUND

• Baccala A, Sercia L, Li J, Heston W, Zhou M. Expression of prostate-specific membrane antigen in tumor-associated neovasculature of renal neoplasms. Urology. 2007 Aug;70(2):385-90. doi: 10.1016/j.urology.2007.03.025.

  PMID: 17826525 BACKGROUND

• Chang SS, Reuter VE, Heston WD, Gaudin PB. Metastatic renal cell carcinoma neovasculature expresses prostate-specific membrane antigen. Urology. 2001 Apr;57(4):801-5. doi: 10.1016/s0090-4295(00)01094-3.

  PMID: 11306418 BACKGROUND

• Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5.

  PMID: 16555021 BACKGROUND

• Prasad V, Steffen IG, Diederichs G, Makowski MR, Wust P, Brenner W. Biodistribution of [(68)Ga]PSMA-HBED-CC in Patients with Prostate Cancer: Characterization of Uptake in Normal Organs and Tumour Lesions. Mol Imaging Biol. 2016 Jun;18(3):428-36. doi: 10.1007/s11307-016-0945-x.

  PMID: 27038316 BACKGROUND

• Park JW, Jo MK, Lee HM. Significance of 18F-fluorodeoxyglucose positron-emission tomography/computed tomography for the postoperative surveillance of advanced renal cell carcinoma. BJU Int. 2009 Mar;103(5):615-9. doi: 10.1111/j.1464-410X.2008.08150.x. Epub 2008 Oct 24.

  PMID: 19007371 BACKGROUND

• Majhail NS, Urbain JL, Albani JM, Kanvinde MH, Rice TW, Novick AC, Mekhail TM, Olencki TE, Elson P, Bukowski RM. F-18 fluorodeoxyglucose positron emission tomography in the evaluation of distant metastases from renal cell carcinoma. J Clin Oncol. 2003 Nov 1;21(21):3995-4000. doi: 10.1200/JCO.2003.04.073.

  PMID: 14581422 BACKGROUND

• Lawrentschuk N, Davis ID, Bolton DM, Scott AM. Functional imaging of renal cell carcinoma. Nat Rev Urol. 2010 May;7(5):258-66. doi: 10.1038/nrurol.2010.40.

  PMID: 20448659 BACKGROUND

• Sawicki LM, Buchbender C, Boos J, Giessing M, Ermert J, Antke C, Antoch G, Hautzel H. Diagnostic potential of PET/CT using a 68Ga-labelled prostate-specific membrane antigen ligand in whole-body staging of renal cell carcinoma: initial experience. Eur J Nucl Med Mol Imaging. 2017 Jan;44(1):102-107. doi: 10.1007/s00259-016-3360-2. Epub 2016 Mar 21.

  PMID: 26996777 BACKGROUND

• Aide N, Cappele O, Bottet P, Bensadoun H, Regeasse A, Comoz F, Sobrio F, Bouvard G, Agostini D. Efficiency of [(18)F]FDG PET in characterising renal cancer and detecting distant metastases: a comparison with CT. Eur J Nucl Med Mol Imaging. 2003 Sep;30(9):1236-45. doi: 10.1007/s00259-003-1211-4. Epub 2003 Jul 4.

  PMID: 12845486 BACKGROUND

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma

Study Officials

• Melissa Huynh, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaydee Connors

CONTACT

519-685-8500; kaydee.connors@lhsc.on.ca

Nicole Phillips

CONTACT

519-685-8500; nicole.phillips@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: January 24, 2022
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)